Symptomatic Malignant Ascites Drainage with a Patient-controlled Vascular Catheter – interim analysis of safety and patients’ reported outcomes

Symptomatic Malignant Ascites Drainage with a Patient-controlled Vascular Catheter – interim analysis of safety and patients’ reported outcomes | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Symptomatic Malignant Ascites Drainage with a Patient-controlled Vascular Catheter – interim analysis of safety and patients’ reported outcomes Maciej Stukan, Marcin Jedryka, Andrej Cokan, Jaroslav Klát, Munachiso Ndukwe Iheme, and 7 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4266210/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 19 Feb, 2025 Read the published version in Supportive Care in Cancer → Version 1 posted 7 You are reading this latest preprint version Abstract Malignant ascites (MA) and repeated paracentesis can impair patient’s quality of life (QOL). The aim was to evaluate changes in patients’ QOL and the safety of MA drainage with a patient-controlled central vascular catheter (CVC) inserted into the abdominal cavity. This is an interim analysis of a prospective, multicentre trial ongoing within the Central and Eastern European Gynaecologic Oncology Group (CEEGOG). CVC (14-Ga) was inserted into the abdominal cavity of patients with symptomatic MA and drainage was controlled by patients at home. The rate and quality of complications were classified according to Common Terminology Criteria for Adverse Events Version 5.0. QOL was evaluated before and 10-14 days after/during drainage with standardized QLQ-C15-PAL, SGA, and FACIT-TS-G questionnaires. Wilcoxon and Chi-squared tests were used. Among 113 recruited patients (2015-2022) 8 adverse events were detected in 7 patients (6.2%), including one serious (death on the 9th day after catheter insertion, classified as not related to the intervention). Other complications were local infection (n=2) (resolved after oral antibiotics), catheter obstruction (n=2), catheter self-removal (n=2) (re-insertion performed), and nausea (n=1). When comparing the assessment before and after/during drainage, we found the significantly better global quality of life (mean 31.8 vs 47.8, p<0.001), improvement in physical (52.6 vs 64.4, p<0.001) and emotional functioning (50.7 vs 65.4, p<0.001); symptoms were significantly less intense: fatigue (66.7 vs 50.9, p<0.001), nausea and vomiting (37.8 vs 21.4, p<0.001), pain (53.9 vs 34.1, p<0.001), dyspnoea (48.5 vs 22.3, p<0.001), insomnia (49.1 vs 34.3, p<0.001), appetite loss (56.3 vs 40.3, p<0.001), constipation (31.0 vs 25.2, p=0.007), and more patients had no pain on eating (71.3% vs 82.9%, p=0.04). Most patients (78%) were satisfied, 83% would recommend the procedure to others, and 90% would choose intervention again. MA drainage via patient-controlled CVC inserted into the abdominal cavity is safe and improves patients’ QOL. Introduction Malignant ascites (MA) is a common symptom of advanced cancer. It can occur in many malignancies and most often is a poor prognostic factor, with only 11% of patients surviving longer than 6 months. Among different primary diseases, ovarian cancer is the most common cause of MA and an exception in terms of the predictive and prognostic significance of MA [ 1 ]. Whichever the primary disease, MA just by its volume and mass adds symptoms and can worsen a patient’s quality of life (QOL), already impaired by the malignancy. Most often oncological systemic treatment for the patient’s primary disease is effective against MA. However, some patients suffer from refractory, symptomatic MA that are resistant to disease-targeted medications, others are not candidates for any oncological treatment but still can suffer from the volume of ascites in addition to other symptoms. In the context of a possible appearance of ascites at different times in the course of the disease, (e.g. it can be the first sign of ovarian cancer, before any oncological treatment), management of symptoms caused by MA should be offered at any time, when the patient could benefit from it in terms of better symptoms control, QOL, as well as part of the preparation to the treatment, not just for the end-stage [ 2 ], and not too late [ 3 ]. Patients presenting with MA require a comprehensive assessment and a management plan that addresses QOL [ 4 ]. There are many different approaches to managing MA, among which drainage is the most often applied and available. It can be performed with repeated paracentesis or via permanently inserted catheters of different types [ 1 ]. This study aimed to perform a pre-planned interim analysis of an ongoing international trial on symptomatic malignant ascites drainage with a patient-controlled vascular catheter inserted into the abdominal cavity, in terms of safety, symptom control, and changes in patient’s QOL. Materials and methods The international, multi-institutional trial entitled “Symptomatic malignant Ascites DRAinage with a PAtient-controlled vascular Catheter” (ADRAPAC) is prospectively conducted within the Central and Eastern European Gynecologic Oncology Group (CEEGOG) (OX-3) and Polish Gynecologic Oncology Group (PGOG) and registered at ClinicalTrials (NCT02724683). Eligible patients were those with symptomatic MA, with every malignant disease, female and male, if a cancer treatment is not effective against ascites, or no oncological systemic treatment is possible. All patients signed an informed consent at screening. A percutaneous placement of a central venous catheter, 14-Ga (2.2mm) (no specific manufacturer) into the abdominal cavity (under ultrasound control) was performed and followed by ascites drainage performed when required, at home or ambulatory. Patients were instructed on how to use the catheter (leaflet plus additional video available at YouTube: https://www.youtube.com/watch?v=MDMNLsL9Czc&t=100s ), and advised to evacuate fluid, if necessary, only, and up to 2000ml per day. A follow-up visit was planned 10–18 days after catheter insertion. If the patient was unable to come in person (e.g. palliative setting) a telephone conversation was performed. Additionally, these patients sent a photo of the catheter, or a video connection was used to visualize the site of catheter insertion. Basic clinical data were collected before catheter insertion. Adverse events were collected every time they appeared (at any control visit) following catheter insertion and classified according to the NCI Common Terminology Criteria for Adverse Events Version 5.0. An additional template was provided for the study-specific potential complications, e.g. catheter obstruction or self-removal. A catheter was kept in situ as long as needed, but not shorter than 14 days. It was deliberately removed later if not needed (e.g. patient received chemotherapy and ascites resolved). Other reasons for catheter removal were classified as complications (e.g. unwanted self-removal, catheter-related infection, obstruction). Changes in patients’ QOL and nutritional habits were evaluated with standardized European Organization for Research and Treatment of Cancer (EORTC) C15-PAL [ 5 ] and SGA (Subjective Global Assessment) [ 6 ] questionnaires respectively. These were reported at 2 time points: before insertion of the catheter, and 10–14 days after/during drainage. Patients’ experience with the treatment was evaluated using the FACIT-TS-G questionnaire [ 7 ], 10–14 days after/during drainage. Permission to use these questionnaires was granted by their developers. Patients were assigned a specific number in the study, that was placed on all questionnaires, to protect patients’ privacy. Statistical analysis Quantitative variables were characterized using the mean, standard deviation, median, range, 95% Confidence Interval (CI), and lower and upper quartiles. In contrast, qualitative variables were represented by frequency counts and percentages. For the model involving two related variables, the Wilcoxon signed-rank test was employed. Chi-square tests of independence were used for qualitative variables. In all calculations, a significance level of p = 0.05 was adopted. At the stage of planning the study, a sample size calculation was performed. To obtain meaningful results, the sample size was estimated for adverse events: 170 patients, for quality of life: 146 patients. It was performed under the following conditions: type I error probability of 0.05, test power of 80%. Based on pilot data from the leading institution, 30% of patients were lost to follow-up (poor condition, palliative setting, and long distance from the hospital). Thus, the optimal target size of the group was established for 220 patients. All statistical analyses were conducted using the StatSoft, Inc. (2014) statistical package, STATISTICA (data analysis software system), version 12.0 ( www.statsoft.com ), and the Excel spreadsheet program. Results From December 2015 to October 2022, we recruited 113 patients. Until April 2021, 2 institutions were recruiting (within PGOG). Since May 2021 more international groups joined the study and contributed to the patients’ enrollment (within CEEGOG). Patients’ characteristics are provided in Table 1, and the number of recruited cases per center is provided in Table 2. Table 1. Patients’ characteristics. Variable Value Age [median (range), years] 64 (31-90) Education Basic Middle Higher Not provided 37 (32.7%) 49 (43.3%) 24 (21.2%) 3 (2.6%) At home: Living with someone Living alone Not provided 97 (85.9%) 15 (13.2%) 1 (0.9%) Referred for drainage from: Hospital department Home Not provided 68 (60.2%) 40 (35.4%) 5 (4.4%) Primary cancer site: Ovary Gastric Pancreas Colon Endometrial Breast Other 80 (70.8%) 6 (5.3%) 6 (5.3%) 4 (3.5%) 3 (2.7%) 2 (1.8%) 12 (10.6%) Status of the disease: Further treatment planned (chemotherapy or surgery) Best supportive care planned. Not known 76 (67.3%) 33 (29.2%) 4 (3.5%) Co-morbidities (list according to Charlson index)[8]: Coronary disease Diabetes Pulmonary obstructive disease Cerebrovascular disease Connective tissue disease Peptic ulcer Liver disease Renal insufficiency Hemiplegia AIDS Other 8 (7.1%) 17 (15.0%) 0 0 2 (1.8%) 1 (0.9%) 6 (5.3%) 0 1 (0.9%) 0 9 (8.0%) BMI [median (range), kg/(m) 2 ] (before drainage) 26.0 (17.3-43.6) Performance status (ECOG*) before insertion of a catheter 0 1 2 3 4 Not provided 1 (0.9%) 27 (23.9%) 53 (46.9%) 26 (23,0%) 1 (0.9%) 5 (4.4%) Symptoms before catheter insertion Dyspnea Lack of appetite Constipation Pain Filling full quickly after eating Abdominal discomfort Vomiting Nausea 73 (64.6%) 81 (71.1%) 13 (11.5%) 68 (60.2%) 74 (65.5%) 89 (78.8%) 23 (20.4%) 52 (46.0%) Previous paracentesis performed (within previous 3 months) 32 (28.3%) Previous oncological treatment (any time in the past): Surgery Chemotherapy 20 (17.7%) 21 (18.6%) * ECOG, Eastern Cooperative Oncology Group Table 2. Number of enrolled patients per site. Institution Country Patients enrolled Wroclaw Oncology Center Poland 57 Gdynia Oncology Center Poland 30 UMC Maribor Slovenia 11 UH Ostrava Czech Republic 8 UH Hradec Králové Czech Republic 7 Table 3. Indications and procedural issues of catheter insertion and drainage. Indications for ascites drainage (can be more than one): Symptoms control Supportive to oncological treatment Other 110 (97.3%) 59 (52.2%) 3 (2.6%) Anesthesia for catheter insertion Local Sedation General 105 (92.9%) 8 (7.1%) 0 Catheter replacement at the time of first insertion required 1 (0.9%) Catheter replacement later (during drainage) 6 (5.3%) Lobulated ascites at the time of first catheter insertion 24 (21.2%) Volume of ascites evacuated at the catheter insertion [median (range), ml] 2000 (0-5000) Volume of ascites evacuated weekly [median (range), ml] 7000 (500-15000) Patient controlling symptoms and satisfied from the procedure – general impression of patient as answered to physician 95 (84.1%) Indications and issues concerned with catheter insertion and drainage follow-up are presented in Table 3. Eight adverse events were detected in 7 patients (6.2%), including one serious adverse event. One patient died 9 days after the catheter insertion. We found no direct relationship between intervention and death. Patients was readmitted to the hospital 3 days after catheter insertion, and deteriorated each day, independently of medical tests and interventions. Peritonitis was excluded. The patient was 70 years old, her primary malignancy was pancreatic cancer, she had no significant co-morbidities, her BMI was 24 kg/m2, she was estimated as PS-1 before catheter insertion, and the procedure was done for palliation only. The median volume of drained ascites was 2000 ml just after the catheter insertion, and 3500 ml during the next 7 days. All other adverse events are presented in Table 4. These were resolved after appropriate management. For the local infection of subcutaneous tissue oral antibiotics were prescribed. For obstructed catheters, their removal was necessary, and the successful insertion of new ones was performed. For self-removal, new catheters were inserted if still needed. For nausea, antimimetics were effective. Table 4. Adverse events and patients’ characteristics. Case AE Grade (grading system) Time since intervention [days] SAE Age Primary malignancy PS Co-morbidities BMI T / P Volume drained 1 Infection, local G2 16 No 73 ovarian 2 hypertension 32 T 1500/c 700/w 2 Catheter obstruction - 3 No 70 ovarian 1 Rectal and breast cancers in anamnesis 27 T 700/c 2500/w 3 Self-removal of the catheter - 73 No 79 ovarian 2 Coronary disease 44 P 1000/c 5000/w 4 Nausea ? 6 No 58 ovarian 1 Hypertension Hyperlipidemia 41 T 500/c 4000/w 5 Self-removal of the catheter - 27 No 58 ovarian 1 Hypertension Hyperlipidemia 41 T 500/c 4000/w 6 Catheter obstruction - 13 No 52 ovarian 2 None 20 T 2000/c 5000/w 7 Infection, local G2 13 No 68 endometrial 3 Hypertension Atrial flutter 33 P 2000/c 3000/w Abbreviation: /c, volume of drained ascites just after catheter insertion; /w, volume of drained ascites per week; AE, adverse event; P, palliation (no oncological treatment); PS, performance status (at the time of catheter insertion); SAE, serious adverse event; T, active oncological treatment QOL was measured based on 112 completed questionnaires before insertion of the catheter and 10-14 days after/ during drainage. Detailed data on changes in QOL are provided in Table 5. During the ascites drainage, with the catheter in situ, versus the state without catheter (before drainage), we found significantly better global QOL (mean 47.8 vs 31.8), improvement in physical (64.4 vs 52.6) and emotional functioning (65.4 vs 50.7). All symptoms evaluated in the questionnaire were significantly less noticeable: fatigue (50.9 vs 66.7), nausea and vomiting (21.4 vs 37.8), pain (34.1 vs 53.9), dyspnea (22.3 vs 48.5), insomnia (34.3 vs 49.1), appetite loss (40.3 vs 56.3) and constipation (25.2 vs 31.0). Table 5. Changes in quality of life, based on the QLQ-C15-PAL questionnaire, before and after/during the ascites drainage with the catheter in situ. Before (n=112) After / during (n=112) P -value Quality of life (global) (QL) <0.000001 1 n 112 106 mean. (SD) 31.8 (19.1) 47.8 (20.6) range 0.0-83.3 0.0-83.3 median 33.3 50.0 95%CI [28.3;35.4] [43.8;51.8] Q1, Q3 16.7, 41.7 33.3, 66.7 Physical functioning (PF) <0.000001 1 n 112 106 mean. (SD) 52.6 (24.2) 64.4 (22.7) range 0.0-100.0 0.0-100.0 median 55.6 66.7 95%CI [48.0;57.1] [60.0;68.7] Q1, Q3 33.3, 66.7 55.6, 77.8 Emotional functioning (EF) <0.000001 1 n 112 106 mean. (SD) 50.7 (28.0) 65.4 (22.1) range 0.0-100.0 0.0-100.0 median 50.0 66.7 95%CI [45.5;56.0] [61.1;69.7] Q1, Q3 33.3, 66.7 50.0, 83.3 Fatigue (FA) <0.000001 1 n 112 106 mean. (SD) 66.7 (25.0) 50.9 (23.7) range 16.7-100.0 0.0-100.0 median 66.7 50.0 95%CI [62.0;71.4] [46.4;55.5] Q1, Q3 50.0, 83.3 33.3, 66.7 Nausea and vomiting (NV) 0.0001 1 n 112 106 mean. (SD) 37.8 (35.1) 21.4 (28.8) range 0.0-100.0 0.0-100.0 median 33.3 0.0 95%CI [31.2;44.4] [15.8;26.9] Q1, Q3 0.0, 66.7 0.0, 33.3 Pain (PA) <0.000001 1 n 112 106 mean. (SD) 53.9 (31.6) 34.1 (25.1) range 0.0-100.0 0.0-100.0 median 66.7 33.3 95%CI [47.9;59.8] [29.3;39.0] Q1, Q3 33.3, 83,3 16.7, 50.0 Dyspnea (DY) <0.000001 1 n 112 106 mean. (SD) 48.5 (31.3) 22.6 (22.3) range 0.0-100.0 0.0-100.0 median 66.7 33.3 95%CI [42.7;54.4] [18.3;26.9] Q1, Q3 33.3, 66.7 0.0, 33.3 Insomnia (SL) 0.0001 1 n 112 106 mean. (SD) 49.1 (31.3) 34.3 (27.0) range 0.0-100.0 0.0-100.0 median 33.3 33.3 95%CI [43.2;55.0] [29.1;39.5] Q1, Q3 33.3, 66.7 0.0, 66.7 Appetite loss (AP) 0.0001 1 n 112 106 mean. (SD) 56.3 (32.6) 40.3 (32.1) range 0.0-100.0 0.0-100.0 median 66.7 33.3 95%CI [50.1;62.4] [34.1;46.4] Q1, Q3 33.3, 66.7 0.0, 66.7 Constipation (CO) 0.0072 1 n 112 106 mean. (SD) 31.0 (34.9) 25.2 (27.5) range 0.0-100.0 0.0-100.0 median 33.3 33.3 95%CI [24.4;37.5] [19.9;30.5] Q1, Q3 0.0, 66.7 0.0, 33.3 1 Wilcoxon test During the period of the first evaluation (10 – 14 days of drainage), we did not see significant changes in the type of diet that patients reported, nor did we note any changes in the SGA general rating. However, during the ascites drainage, with the catheter in situ, versus the state without the catheter (before drainage), significantly more patients had no pain on eating (82.9% vs 71.3%, p=0.04), no nausea (66.0% vs 47.3%, p=0.005) (1.9% experienced severe nausea during the drainage versus 15.5% before catheter insertion, p<0,001), no vomiting (89.5% vs 74.3%, p=0,004), no diarrhea (93.3% vs 81.5%, p=0,009). Of note is that none of the patients had to come for repeated paracentesis, but those who had their catheter obstructed (re-insertion). All of them were able to drain their ascites alone, at home. According to the results of the FACIT-TS-G questionnaire, 78% were satisfied with the intervention completely or for the most part, 83% would recommend the procedure to others with the same condition, and 90% would again undergo ascites drainage with the catheter if they needed it. Details are provided in Table 6. Table 6. Selected results of the FACIT-TS-G questionnaire – after/during drainage: patients experience with drainage via the central venous catheter inserted into the abdominal cavity (N=105). No, not at all (%) Yes, to some extent (%) Yes, for the most part (%) Yes, completely (%) Do you feel you received the treatment that was right for you? 0 16% 49% 35% Are you satisfied with the effects of this treatment so far? 0 22% 48% 30% No (%) Maybe (%) Yes (%) Would you recommend this treatment to others with your illness? 0 17% 83% Would you choose this treatment again? 1% 9% 90% Poor (%) Fair (%) Good (%) Very Good (%) Excellent (%) How do you rate this treatment overall? 0 1% 44% 45% 10% Discussion Drainage of symptomatic MA via CVC was safe, provided improvements in some functional QOL scales, diminished all evaluated symptoms, and was positively assessed by patients who had undergone the intervention. Safety In a systematic review, generally, 19.7% (255/1297) of patients experienced any complication and 6.2% (81/1297) experienced serious adverse events (SAE) during MA drainage. The rate of complications was different for different drainage methods. After paracentesis for various malignancies, the rate of complications was: 0%–8% (SAE: 0%–5%); drainage using a CVC: 9%–25% (SAE: 0%); permanent peritoneal port: 4%–79% (SAE 0%–4%); tunneled peritoneal catheters: 8%–56% (SAE 0%–39%); for PleurX: 8%–56% (SAE 0%–12%); for Tenckhoff: 9%–29% (SAE 0%); and peritoneovenous shunts: 26%–55% (SAE 5%–33%). The most serious procedure-related complications were reported for peritoneovenous shunts (mortality from pulmonary edema and thromboembolism) [1]. Later published data generally confirmed a relatively safe profile of MA drainage with paracentesis and drains [9-12]. However, some details need attention. One-time insertion of a permanent catheter (also vascular catheter) into the abdominal cavity should be performed under ultrasound control to minimize the risk of potential injuries (bowel, vascular, other) related to the procedure of insertion. If done without imaging control can end with fatal bowel perforation (1% of a cohort undergoing drainage) [11]. Peritonitis is one of the most significant and serious adverse events of prolonged ascites drainage via permanent catheters [1]. Also, in more recent publications peritonitis is still an important issue, that is reported with different frequencies: 1% with paracentesis / indwelling catheter (pigtail) [11]; 2% with the usage of the peritoneal catheter [10], however information on the outcome of the complication is lacking in both cited studies. There were 4.4% peritonitis (6/137) complications after drainage of ascites via a tunneled peritoneal catheter (PleurX, 19-gauge), and one catheter-associated death (bacterial peritonitis; 0.8%) [12]. In another study, where tunneled indwelling peritoneal catheters were placed for the management of recurrent MA in 48 patients, the rate of bacterial peritonitis was as high as 8.8%, with all patients responding to antibiotics and only one required catheter removal [13]. Chen et al reported retrospectively on outcomes of 26 patients with inserted tunneled intraperitoneal ports (subcutaneous). Interestingly, the mean number of times each port was accessed was 10 (range: 1–90), which was possible at patients’ homes too, so prevented repeated paracentesis. However, reported rates of cellulitis and peritonitis were 7% and 12% per patient and per port, respectively. Unfortunately, the authors did not provide management and outcomes of peritonitis [9]. It seems that either there must be some additional risk factors that peritonitis may become lethal (e.g. performance status, end-stage malignancy), or there are different definitions of peritonitis. An example of a very broad peritonitis definition was used by Chen et al: peritonitis was defined by abdominal pain or fever with ascites and an absolute neutrophil count greater than 250 cells per microlitre and/or positive ascites fluid or blood culture [9]. Of note is one study because its results differ from others [14]. In a retrospective, observational study, bacterial colonization of the catheter without immediate infection was noted after a mean time of 18 days in 69 of 143 patients following catheter insertion (43,5%). After a median of 14.5 days, thirty patients developed drain-related infection, accounting for 43.5% of those with prior positive bacterial colonization of the drain and 21% of all patients. Among those (n=69), 5 (7,2%) developed drain-related peritonitis, and 4 died from the infection (80% of deaths after the diagnosis of peritonitis, and 13.3% of deaths among all patients who developed drain-related infection). Other forms of infection were defined as drain-site cellulitis (20%), infected ascitic fluid without clinical features of peritonitis (26.7%), fever or sepsis without other demonstrable foci (10%), and physician-diagnosed drain-related infection (36.7%) [14]. One must note that the frequency of infection complications was higher in the Chan et al. group as compared to previously reported (0 – 1.9% for G2 infections, and 0 – 5.7% for G3 infections) [1]. Notably, one-third of the patients had hepatocellular carcinoma (HCC), and 27.5% of the patients had comorbid liver cirrhosis, and the multivariate analysis revealed that HCC [odds ratio (OR): 8.85; 95% confidence interval (CI): 1.86–42.07, P=0.006] and decrease in body weight (OR: 1.20; 95% CI: 1.02–1.42, P=0.03) were the only risk factors for developing infection complications [14]. The probable explanation for the higher risk and incidence of ascitic fluid infection among patients with liver failure was described elsewhere [15]. The risk of peritonitis during ascites drainage was higher in patients with end-stage liver disease (8.3%) [16] than in those with other malignancies (2.5%) [17]. Based on the research discussed herein, we should acknowledge a difference in the risk of infection during ascites drainage, between patients with ascites secondary to massive liver involvement (e.g., HCC, liver metastases) versus peritoneal carcinomatosis. These patients should probably be independently analyzed in future research studies [18], however, it is debatable [19]. The larger the diameter of a catheter, the more risk of complications, including infections [20]. Dedicated peritoneal catheters (e.g. PleurX) have larger diameters (5.2 mm) [10], than vascular catheters (2.2 mm) inserted into the abdominal cavity [21]. Also, the longer catheter dwell time the higher the risk of infectious complications [12]. Hyponatremia is another possible complication of prolonged MA drainage, however it may not have clinical significance, because it is often untreated or unrecognized. Nevertheless, a risk group of patients with hepatopancreatobiliary malignancy and hyponatremia before drainage was suggested for routine testing of plasma sodium concentration, because hyponatremia may have significant negative implications [22]. In another study sodium values declined both pre- and post-procedure (tunneled catheter insertion followed by drainage); the slope of decline diminished postprocedure compared with pre-procedure (sodium slope [–2.50 to 1.31 mEq/L, p = 0.037]). No clinical relevance of the laboratory results was provided [23]. Loculation of ascites is another complication that can happen in 2% of patients [13] after prolonged drainage, or repeated paracentesis. It needs to be addressed because no single drain can solve the problem . It seems that the variability in mean arterial pressure during drainage of MA is not dependent on drainage volume (two groups were compared: drainage of large (5-10 L) vs small (<5 L) volume) [24]. However, the “drainage to dryness” should not be the aim. It was shown that even small-volume (1.5-2.5 L) paracentesis could alleviate abdominal distension of terminally ill cancer patients with MA without shortening the paracentesis interval compared with moderate-volume (>2.5 L) paracentesis. Only drainage of a minimal volume (<1.5 L) was the risk factor (HR: 2.34) for a shorter interval to the next paracentesis [25]. In the case of permanently placed drains/catheters, the repeating paracentesis is not the case. Thus, the ascites drainage volume should rather be adapted to individual patients, with the main aim of controlling symptoms and improving QOL. Additionally, in one study it was shown that the median mass of MA was 3 240 – 3 480 g, with a maximum as high as 14 350 g [26], thus evacuation of ascites may increase a patient’s mobility. QOL QOL measured with EORTC QLQ-C30 before paracentesis for MA revealed that global QOL and emotional functioning were worse in patients with MA [26] as compared to a reference of all cancer patients [27] (38.9-41.1 vs 61.3 and 56.3-61.6 vs 71.4, respectively). Also, symptoms were more severe among patients with MA [26] than the reference [27] (24.7-63.4 vs 9.1-34.6) [26] . QOL before and after drainage can be measured with simple scales. In a small retrospective study (n=30), on a 10-point scale, QOL compared to that before subcutaneous peritoneal and pleural port catheter placement, improvement was rated a mean of 9.5 by patients and 9.0 by the nursing staff. Both patients and nurses reported a high degree of convenience (rated at 9.7 and 9.6, respectively) and improvement of symptoms and comfort (9.6 and 9.3, respectively) [28]. In a prospective, longitudinal study of patients with refractory ascites associated with stage IV or end-stage malignancy who underwent percutaneous tunneled catheters (Tenckhoff) insertion in interventional radiology at a single institution, QOL was tested with EORTC QLQ-C30 and McGill QOL questionnaires, prior the procedure (n=47) and at 1 (n=37) and 3 (n=20) weeks during the drainage. A significant improvement was demonstrated in global QOL, functional role, emotional, and cognitive scales at 1 week. Also, significant symptom improvement was seen in fatigue, nausea/vomiting, pain, dyspnea, insomnia, and appetite loss. This improvement was sustained at 3 weeks for dyspnea, insomnia, and appetite [23]. In a longitudinal study that captured patient responses on selected symptoms and QOL instruments immediately before and 24 h after paracentesis for symptomatic ascites, it was shown that the evacuation of the fluid significantly improved mobility, appetite, decreased shortness of breath, fatigue, and level of anxiety and depression. It also improved role functioning, however had no impact on global QOL nor the social and physical functioning, and caused worse cognitive functioning [4]. Easson et al. evaluated the measurement properties of selected existing validated symptom and QOL questionnaires in patients undergoing paracentesis for symptomatic ascites. They tested 4 different questionnaires and suggested that the EORTC QLQ-C30 and the ESAS:AM (Edmonton Symptom Assessment System–Ascites Modification) together, or the QLQ-C30 with the addition of the QLQ-PAN26 (EORTC 26-item pancreatic cancer module) ascites and abdominal pain subscales could be used [29]. However, these questionnaires are complex and may not be suitable for many patients suffering symptoms of ascites and advanced malignancy. According to our observations, most patients are reluctant to concentrate on reading, understanding, and completing complex questionnaires. Their primary goal is to handle symptoms and they often face anxiety and depression. Thus, if completed under pressure, the results of complex questionnaires may be significantly biased. That is why we decided to use the shortest and easiest possible validated tools to assess QOL changes. Others measured changes in QOL by a systematic telephone review focusing on ascites-associated symptoms (using a five-point scale). The abdominal discomfort, impaired mobility, dyspnea, fatigue, nausea, and vomiting were significantly reduced 30 days after PleurX (tunneled, permanent drain) insertion (p<0.05) [10]. Other considerations In a palliative setting, median survival after drain insertion was 19 days (one-third survived less than 2 weeks). Thus, Murray et al suggested that in cases with symptomatic ascites, insertion of drains and drainage should not be delayed [3]. Contrary, in the study by Wimberger et al. QOL of patients undergoing repeated paracentesis for MA were tested for up to 7 months (no data on overall survival). Importantly, half of the patients had ovarian cancer in this trial [26]. In another cohort, median survival was 38 days after placement of tunneled drainage catheters (ovarian cancer constituted 18.8%) [23]. Thus, the timing of catheter insertion for permanent ascites drainage should be individually considered and not delayed for symptomatic patients. It is even more important if larger procedures, like tunneled catheter implantation, are planned. As suggested by Korpi et al., patients with ascites secondary to advanced pancreatic cancer may as well benefit from repeated paracentesis, instead of being subjected to more invasive procedures like insertion of larger catheters [30]. Of note is that smaller catheters, like the CVC, can be easily inserted, even in an ambulatory setting as shown in our study and the previous ones [21, 31, 32]. Another issue is the economy. According to research by Wu et al. tunneled peritoneal catheter was the most cost-effective strategy when compared to repeated large-volume paracentesis in patients with recurrent ascites from gynecological malignancy [33]. Even more significant economic benefit may be expected if CVC was used because the procedure of insertion is much easier than it is for tunneled catheters. The limitations of our study include the population of patients with MA, among which ovarian cancer patients were the most frequent, results are based on prerequisite data collection tools, and the main settings of recruiting institutions were cancer centers (not palliative departments) and thus our results may not be generalized to all clinical settings. Conclusion MA drainage via patient-controlled CVC inserted into the abdominal cavity is safe and improves patients’ QOL. It can be considered supportive management, whenever required, from the moment of diagnosis until the end-life stage. The research is ongoing with more institutions involved. Thus, we expect to provide robust data on a larger patient cohort. Declarations Disclosures and declarations The authors have no relevant financial or non-financial interests to disclose. There was no funding. Authors contributions Maciej Stukan, David Cibula, and Radosław Mądry contributed to the study conception and design. Material preparation and data collection were done by Marcin Jędryka, Andrej Cokan, Jaroslav Klat, Munachiso Ndukwe Iheme Jr., Marcin Kryszpin, Renata Pobłocka, Eva Timošek, Martina Romanová, Klára Kolařová. Analysis of data was performed by Maciej Stukan. The first draft of the manuscript was written by Maciej Stukan and all authors could have commented on previous versions of the manuscript. All authors read and approved the final manuscript. Ethics approval This study was performed in line with the principles of the Declaration of Helsinki. Ethical Committee by Medical Council in Gdansk, Poland approved the study protocol and its amendments (KB 17/15, KB 18/16, KB 15/17, KB 16/20), and additional local approvals were obtained by each participating center. Data repository The database of this study is not publicly available. Interested researchers who provide a methodologically sound proposal can access de-identified data. References Stukan M (2017) Drainage of malignant ascites: patient selection and perspectives. Cancer Manag Res 9:115–130. doi: 10.2147/cmar.S100210 Hui D, Bruera E (2016) Integrating palliative care into the trajectory of cancer care. Nature reviews Clinical oncology 13 (3):159–171. doi: 10.1038/nrclinonc.2015.201 Murray FR, Gnehm F, Schindler V, Morell B, Gubler C, Kretschmer EM, Bütikofer S (2022) Permanent Tunneled Drainage of Ascites in Palliative Patients: Timing Needs Evaluation. J Palliat Med 25 (7):1132–1135. doi: 10.1089/jpm.2021.0506 Husain A, Bezjak A, Easson A (2010) Malignant ascites symptom cluster in patients referred for paracentesis. Ann Surg Oncol 17 (2):461–469. doi: 10.1245/s10434-009-0774-0 Groenvold M, Petersen MA, Aaronson NK, Arraras JI, Blazeby JM, Bottomley A, Fayers PM, de Graeff A, Hammerlid E, Kaasa S, Sprangers MA, Bjorner JB (2006) The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. European journal of cancer (Oxford, England: 1990) 42 (1):55–64. doi: 10.1016/j.ejca.2005.06.022 Duerksen DR, Laporte M, Jeejeebhoy K (2021) Evaluation of Nutrition Status Using the Subjective Global Assessment: Malnutrition, Cachexia, and Sarcopenia. Nutr Clin Pract 36 (5):942–956. doi: 10.1002/ncp.10613 Peipert JD, Beaumont JL, Bode R, Cella D, Garcia SF, Hahn EA (2014) Development and validation of the functional assessment of chronic illness therapy treatment satisfaction (FACIT TS) measures. Qual Life Res 23 (3):815–824. doi: 10.1007/s11136-013-0520-8 Charlson ME, Pompei P, Ales KL, MacKenzie CR (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. Journal of chronic diseases 40 (5):373–383. doi: 10.1016/0021-9681(87)90171-8 Chen BS, Wong SHC, Hawkins S, Huggins L (2018) Permanent peritoneal ports for the management of recurrent malignant ascites: a retrospective review of safety and efficacy. Intern Med J 48 (12):1524–1528. doi: 10.1111/imj.14137 Petzold G, Bremer SCB, Heuschert FC, Treiber H, Ellenrieder V, Kunsch S, Neesse A (2021) Tunnelled Peritoneal Catheter for Malignant Ascites-An Open-Label, Prospective, Observational Trial. Cancers (Basel) 13 (12). doi: 10.3390/cancers13122926 Seah DS, Wilcock A, Chang S, Sousa MS, Sinnarajah A, Teoh CO, Allan S, Chye R, Doogue M, Hunt J, Agar M, Currow DC (2022) Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study. Palliative medicine 36 (9):1408–1417. doi: 10.1177/02692163221122326 Knight JA, Thompson SM, Fleming CJ, Bendel EC, Neisen MJ, Neidert NB, Stockland AH, Bjarnason H, Woodrum DA (2018) Safety and Effectiveness of Palliative Tunneled Peritoneal Drainage Catheters in the Management of Refractory Malignant and Non-malignant Ascites. Cardiovascular and interventional radiology 41 (5):753–761. doi: 10.1007/s00270-017-1872-1 Chan KP, Badiei A, Tan CPS, Fitzgerald DB, Stanley C, Fysh ETH, Shrestha R, Muruganandan S, Read CA, Thomas R, Lee YCG (2020) Use of indwelling pleural/peritoneal catheter in the management of malignant ascites: a retrospective study of 48 patients. Intern Med J 50 (6):705–711. doi: 10.1111/imj.14642 Chan PC, Cheung KWA, Chan CH, Hwang LM, Lo SH (2020) Patterns and infection outcomes of bacterial colonization in patients with indwelling abdominal drains for malignant ascites. Annals of palliative medicine 9 (6):4490–4501. doi: 10.21037/apm.2019.09.15 Piano S, Tonon M, Angeli P (2018) Management of ascites and hepatorenal syndrome. Hepatology International 12 (1):122–134. doi: 10.1007/s12072-017-9815-0 Solbach P, Höner Zu Siederdissen C, Taubert R, Ziegert S, Port K, Schneider A, Hueper K, Manns MP, Wedemeyer H, Jaeckel E (2017) Home-based drainage of refractory ascites by a permanent-tunneled peritoneal catheter can safely replace large-volume paracentesis. Eur J Gastroenterol Hepatol 29 (5):539–546. doi: 10.1097/meg.0000000000000837 Wong BCT, Cake L, Kachuik L, Amjadi K (2015) Indwelling Peritoneal Catheters for Managing Malignancy-Associated Ascites. Journal of Palliative Care 31 (4):243–249. doi: 10.1177/082585971503100406 Stukan M (2020) Malignant ascites drainage with indwelling abdominal catheters: can we predict and prevent infection complication? Annals of palliative medicine 9 (2):136–140. doi: 10.21037/apm.2019.11.29 Aujayeb A, Jackson K (2020) Infection in indwelling peritoneal catheters for malignant ascites. Annals of palliative medicine 9 (3):1280–1281. doi: 10.21037/apm.2020.03.11 Türk Y, Devecioğlu İ, Yıldızhan İ, Arslan BC, Arıbaş BK (2022) Tunneled Uncuffed Pigtail Drainage Catheter Placement in Patients with Refractory Ascites or Pleural Effusion: A Single-Center Experience. Cardiovascular and interventional radiology 45 (11):1735–1741. doi: 10.1007/s00270-022-03248-2 Stukan M, Lesniewski-Kmak K, Wroblewska M, Dudziak M (2015) Management of symptomatic ascites and post-operative lymphocysts with an easy-to-use, patient-controlled, vascular catheter. Gynecologic oncology 136 (3):466–471. doi: 10.1016/j.ygyno.2014.11.073 Gupta S, Tio MC, Gutowski ED, Stecker MS, Verma A, Motwani SS, Mount DB, McMahon GM, Waikar SS (2020) Incidence of Hyponatremia in Patients With Indwelling Peritoneal Catheters for Drainage of Malignant Ascites. JAMA Netw Open 3 (10):e2017859. doi: 10.1001/jamanetworkopen.2020.17859 Robson PC, Gonen M, Ni A, Brody L, Brown KT, Getrajdman G, Thom B, Kline N, Covey A (2019) Quality of life improves after palliative placement of percutaneous tunneled drainage catheter for refractory ascites in prospective study of patients with end-stage cancer. Palliat Support Care 17 (6):677–685. doi: 10.1017/s1478951519000051 Kawamura T, Tanaka N, Hori M, Inoue KI, Kawamura M, Matsusaki K (2023) Hemodynamic Variability During Drainage of Large Volumes of Malignant Ascites in Patients With Cancer. Clin Nurs Res 32 (4):815–820. doi: 10.1177/10547738231157157 Ito T, Yokomichi N, Ishiki H, Kawaguchi T, Masuda K, Tsukuura H, Funaki H, Suzuki K, Oya K, Nakagawa J, Mori M, Yamaguchi T (2021) Optimal Paracentesis Volume for Terminally Ill Cancer Patients With Ascites. Journal of pain and symptom management 62 (5):968–977. doi: 10.1016/j.jpainsymman.2021.04.010 Wimberger P, Gilet H, Gonschior AK, Heiss MM, Moehler M, Oskay-Oezcelik G, Al-Batran SE, Schmalfeldt B, Schmittel A, Schulze E, Parsons SL (2012) Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone. Annals of oncology: official journal of the European Society for Medical Oncology / ESMO 23 (8):1979–1985. doi: 10.1093/annonc/mds178 Scott N, Fayers P, Aaronson N, Bottomley A, de Graeff A, Groenvold M, Gundy C, Koller M, Petersen M, Sprangers M (2008) EORTC QLQ-C30 Reference Values. Monsky WL, Yoneda KY, MacMillan J, Deutsch LS, Dong P, Hourigan H, Schwartz Y, Magee S, Duffield C, Boak T, Cernilia J (2009) Peritoneal and pleural ports for management of refractory ascites and pleural effusions: assessment of impact on patient quality of life and hospice/home nursing care. J Palliat Med 12 (9):811–817. doi: 10.1089/jpm.2009.0061 Easson AM, Bezjak A, Ross S, Wright JG (2007) The ability of existing questionnaires to measure symptom change after paracentesis for symptomatic ascites. Ann Surg Oncol 14 (8):2348–2357. doi: 10.1245/s10434-007-9370-3 Korpi S, Salminen VV, Piili RP, Paunu N, Luukkaala T, Lehto JT (2018) Therapeutic Procedures for Malignant Ascites in a Palliative Care Outpatient Clinic. J Palliat Med 21 (6):836–841. doi: 10.1089/jpm.2017.0616 Mercadante S, Intravaia G, Ferrera P, Villari P, David F (2008) Peritoneal catheter for continuous drainage of ascites in advanced cancer patients. Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer 16 (8):975–978. doi: 10.1007/s00520-008-0453-x Gu X, Zhang Y, Cheng M, Liu M, Zhang Z, Cheng W (2016) Management of non-ovarian cancer malignant ascites through indwelling catheter drainage. BMC Palliat Care 15:44. doi: 10.1186/s12904-016-0116-5 Wu X, Keller EJ, Rabei R, Rockwell H, Beeson S, Heller M, Kothary N (2022) Cost-effectiveness of tunneled peritoneal catheters versus repeat paracenteses for recurrent ascites in gynecologic malignancies. Gynecologic oncology 164 (3):639–644. doi: 10.1016/j.ygyno.2022.01.011 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 19 Feb, 2025 Read the published version in Supportive Care in Cancer → Version 1 posted Editorial decision: Revision requested 28 Dec, 2024 Reviews received at journal 22 Jul, 2024 Reviewers agreed at journal 27 Jun, 2024 Reviewers invited by journal 28 May, 2024 Editor assigned by journal 28 May, 2024 Submission checks completed at journal 25 Apr, 2024 First submitted to journal 14 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4266210","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":295622950,"identity":"3e823fb2-0903-4324-82a3-44b6ef759a53","order_by":0,"name":"Maciej 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Maribor","correspondingAuthor":false,"prefix":"","firstName":"Eva","middleName":"","lastName":"Timošek","suffix":""},{"id":295622968,"identity":"136d4288-cf12-441f-a819-80ec4b5623a7","order_by":8,"name":"Martina Romanová","email":"","orcid":"","institution":"University Hospital Ostrava","correspondingAuthor":false,"prefix":"","firstName":"Martina","middleName":"","lastName":"Romanová","suffix":""},{"id":295622969,"identity":"a4b5554d-a698-400e-9354-9b52780fe308","order_by":9,"name":"Klára Kolarová","email":"","orcid":"","institution":"UH Hradec Králové","correspondingAuthor":false,"prefix":"","firstName":"Klára","middleName":"","lastName":"Kolarová","suffix":""},{"id":295622970,"identity":"4096e53e-7009-4968-9bb3-86f1a02a2764","order_by":10,"name":"Radoslaw Madry","email":"","orcid":"","institution":"Oncology Clinic, Medical University of Poznan","correspondingAuthor":false,"prefix":"","firstName":"Radoslaw","middleName":"","lastName":"Madry","suffix":""},{"id":295622971,"identity":"61278d43-30db-4d73-995a-6b09fd6fbdb8","order_by":11,"name":"David Cibula","email":"","orcid":"","institution":"Charles University and General University Hospital","correspondingAuthor":false,"prefix":"","firstName":"David","middleName":"","lastName":"Cibula","suffix":""}],"badges":[],"createdAt":"2024-04-14 20:14:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4266210/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4266210/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00520-025-09265-4","type":"published","date":"2025-02-19T15:56:56+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":77052543,"identity":"4b84792e-d781-4a1f-9111-5c6f34fa5708","added_by":"auto","created_at":"2025-02-24 16:14:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":874529,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4266210/v1/61338a38-1920-4f0b-98d5-4e449979c9fe.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Symptomatic Malignant Ascites Drainage with a Patient-controlled Vascular Catheter – interim analysis of safety and patients’ reported outcomes","fulltext":[{"header":"Introduction","content":"\u003cp\u003eMalignant ascites (MA) is a common symptom of advanced cancer. It can occur in many malignancies and most often is a poor prognostic factor, with only 11% of patients surviving longer than 6 months. Among different primary diseases, ovarian cancer is the most common cause of MA and an exception in terms of the predictive and prognostic significance of MA [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Whichever the primary disease, MA just by its volume and mass adds symptoms and can worsen a patient\u0026rsquo;s quality of life (QOL), already impaired by the malignancy.\u003c/p\u003e \u003cp\u003eMost often oncological systemic treatment for the patient\u0026rsquo;s primary disease is effective against MA. However, some patients suffer from refractory, symptomatic MA that are resistant to disease-targeted medications, others are not candidates for any oncological treatment but still can suffer from the volume of ascites in addition to other symptoms. In the context of a possible appearance of ascites at different times in the course of the disease, (e.g. it can be the first sign of ovarian cancer, before any oncological treatment), management of symptoms caused by MA should be offered at any time, when the patient could benefit from it in terms of better symptoms control, QOL, as well as part of the preparation to the treatment, not just for the end-stage [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], and not too late [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Patients presenting with MA require a comprehensive assessment and a management plan that addresses QOL [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. There are many different approaches to managing MA, among which drainage is the most often applied and available. It can be performed with repeated paracentesis or via permanently inserted catheters of different types [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis study aimed to perform a pre-planned interim analysis of an ongoing international trial on symptomatic malignant ascites drainage with a patient-controlled vascular catheter inserted into the abdominal cavity, in terms of safety, symptom control, and changes in patient\u0026rsquo;s QOL.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cp\u003eThe international, multi-institutional trial entitled \u0026ldquo;Symptomatic malignant Ascites DRAinage with a PAtient-controlled vascular Catheter\u0026rdquo; (ADRAPAC) is prospectively conducted within the Central and Eastern European Gynecologic Oncology Group (CEEGOG) (OX-3) and Polish Gynecologic Oncology Group (PGOG) and registered at ClinicalTrials (NCT02724683).\u003c/p\u003e \u003cp\u003eEligible patients were those with symptomatic MA, with every malignant disease, female and male, if a cancer treatment is not effective against ascites, or no oncological systemic treatment is possible. All patients signed an informed consent at screening. A percutaneous placement of a central venous catheter, 14-Ga (2.2mm) (no specific manufacturer) into the abdominal cavity (under ultrasound control) was performed and followed by ascites drainage performed when required, at home or ambulatory. Patients were instructed on how to use the catheter (leaflet plus additional video available at YouTube: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.youtube.com/watch?v=MDMNLsL9Czc\u0026amp;t=100s\u003c/span\u003e\u003cspan address=\"https://www.youtube.com/watch?v=MDMNLsL9Czc\u0026amp;t=100s\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e), and advised to evacuate fluid, if necessary, only, and up to 2000ml per day. A follow-up visit was planned 10\u0026ndash;18 days after catheter insertion. If the patient was unable to come in person (e.g. palliative setting) a telephone conversation was performed. Additionally, these patients sent a photo of the catheter, or a video connection was used to visualize the site of catheter insertion.\u003c/p\u003e \u003cp\u003eBasic clinical data were collected before catheter insertion. Adverse events were collected every time they appeared (at any control visit) following catheter insertion and classified according to the NCI Common Terminology Criteria for Adverse Events Version 5.0. An additional template was provided for the study-specific potential complications, e.g. catheter obstruction or self-removal. A catheter was kept in situ as long as needed, but not shorter than 14 days. It was deliberately removed later if not needed (e.g. patient received chemotherapy and ascites resolved). Other reasons for catheter removal were classified as complications (e.g. unwanted self-removal, catheter-related infection, obstruction).\u003c/p\u003e \u003cp\u003eChanges in patients\u0026rsquo; QOL and nutritional habits were evaluated with standardized European Organization for Research and Treatment of Cancer (EORTC) C15-PAL [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] and SGA (Subjective Global Assessment) [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] questionnaires respectively. These were reported at 2 time points: before insertion of the catheter, and 10\u0026ndash;14 days after/during drainage. Patients\u0026rsquo; experience with the treatment was evaluated using the FACIT-TS-G questionnaire [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], 10\u0026ndash;14 days after/during drainage. Permission to use these questionnaires was granted by their developers. Patients were assigned a specific number in the study, that was placed on all questionnaires, to protect patients\u0026rsquo; privacy.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eQuantitative variables were characterized using the mean, standard deviation, median, range, 95% Confidence Interval (CI), and lower and upper quartiles. In contrast, qualitative variables were represented by frequency counts and percentages. For the model involving two related variables, the Wilcoxon signed-rank test was employed. Chi-square tests of independence were used for qualitative variables. In all calculations, a significance level of p\u0026thinsp;=\u0026thinsp;0.05 was adopted.\u003c/p\u003e \u003cp\u003eAt the stage of planning the study, a sample size calculation was performed. To obtain meaningful results, the sample size was estimated for adverse events: 170 patients, for quality of life: 146 patients. It was performed under the following conditions: type I error probability of 0.05, test power of 80%. Based on pilot data from the leading institution, 30% of patients were lost to follow-up (poor condition, palliative setting, and long distance from the hospital). Thus, the optimal target size of the group was established for 220 patients.\u003c/p\u003e \u003cp\u003eAll statistical analyses were conducted using the StatSoft, Inc. (2014) statistical package, STATISTICA (data analysis software system), version 12.0 (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e\u003ca href=\"https://www.youtube.com/watch?v=MDMNLsL9Czc\u0026amp;t=100s\" target=\"_blank\"\u003ewww.statsoft.com\u003c/a\u003e\u003c/span\u003e\u003cspan address=\"http://www.statsoft.com\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e), and the Excel spreadsheet program.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eFrom December 2015 to October 2022, we recruited 113 patients. Until April 2021, 2 institutions were recruiting (within PGOG). Since May 2021 more international groups joined the study and contributed to the patients\u0026rsquo; enrollment (within CEEGOG). Patients\u0026rsquo; characteristics are provided in Table 1, and the number of recruited cases per center is provided in Table 2.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 1. Patients\u0026rsquo; characteristics.\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eVariable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003eValue\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eAge [median (range), years]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e64 (31-90)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eEducation\u003c/p\u003e\n \u003cp\u003eBasic\u003c/p\u003e\n \u003cp\u003eMiddle\u003c/p\u003e\n \u003cp\u003eHigher\u003c/p\u003e\n \u003cp\u003eNot provided\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e37 (32.7%)\u003c/p\u003e\n \u003cp\u003e49 (43.3%)\u003c/p\u003e\n \u003cp\u003e24 (21.2%)\u003c/p\u003e\n \u003cp\u003e3 (2.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eAt home:\u003c/p\u003e\n \u003cp\u003eLiving with someone\u003c/p\u003e\n \u003cp\u003eLiving alone\u003c/p\u003e\n \u003cp\u003eNot provided\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e97 (85.9%)\u003c/p\u003e\n \u003cp\u003e15 (13.2%)\u003c/p\u003e\n \u003cp\u003e1 (0.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eReferred for drainage from:\u003c/p\u003e\n \u003cp\u003eHospital department\u003c/p\u003e\n \u003cp\u003eHome\u003c/p\u003e\n \u003cp\u003eNot provided\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e68 (60.2%)\u003c/p\u003e\n \u003cp\u003e40 (35.4%)\u003c/p\u003e\n \u003cp\u003e5 (4.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003ePrimary cancer site:\u003c/p\u003e\n \u003cp\u003eOvary\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eGastric\u003c/p\u003e\n \u003cp\u003ePancreas\u003c/p\u003e\n \u003cp\u003eColon\u003c/p\u003e\n \u003cp\u003eEndometrial\u003c/p\u003e\n \u003cp\u003eBreast\u003c/p\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e80 (70.8%)\u003c/p\u003e\n \u003cp\u003e6 (5.3%)\u003c/p\u003e\n \u003cp\u003e6 (5.3%)\u003c/p\u003e\n \u003cp\u003e4 (3.5%)\u003c/p\u003e\n \u003cp\u003e3 (2.7%)\u003c/p\u003e\n \u003cp\u003e2 (1.8%)\u003c/p\u003e\n \u003cp\u003e12 (10.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eStatus of the disease:\u003c/p\u003e\n \u003cp\u003eFurther treatment planned (chemotherapy or surgery)\u003c/p\u003e\n \u003cp\u003eBest supportive care planned.\u003c/p\u003e\n \u003cp\u003eNot known\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e76 (67.3%)\u003c/p\u003e\n \u003cp\u003e33 (29.2%)\u003c/p\u003e\n \u003cp\u003e4 (3.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eCo-morbidities (list according to Charlson index)[8]:\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eCoronary disease\u003c/p\u003e\n \u003cp\u003eDiabetes\u003c/p\u003e\n \u003cp\u003ePulmonary obstructive disease\u003c/p\u003e\n \u003cp\u003eCerebrovascular disease\u003c/p\u003e\n \u003cp\u003eConnective tissue disease\u003c/p\u003e\n \u003cp\u003ePeptic ulcer\u003c/p\u003e\n \u003cp\u003eLiver disease\u003c/p\u003e\n \u003cp\u003eRenal insufficiency\u003c/p\u003e\n \u003cp\u003eHemiplegia\u003c/p\u003e\n \u003cp\u003eAIDS\u003c/p\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e8 (7.1%)\u003c/p\u003e\n \u003cp\u003e17 (15.0%)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003cp\u003e2 (1.8%)\u003c/p\u003e\n \u003cp\u003e1 (0.9%)\u003c/p\u003e\n \u003cp\u003e6 (5.3%)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003cp\u003e1 (0.9%)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003cp\u003e9 (8.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eBMI [median (range), kg/(m)\u003csup\u003e2\u003c/sup\u003e] (before drainage)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e26.0 (17.3-43.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003ePerformance status (ECOG*) before insertion of a catheter\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003cp\u003eNot provided\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1 (0.9%)\u003c/p\u003e\n \u003cp\u003e27 (23.9%)\u003c/p\u003e\n \u003cp\u003e53 (46.9%)\u003c/p\u003e\n \u003cp\u003e26 (23,0%)\u003c/p\u003e\n \u003cp\u003e1 (0.9%)\u003c/p\u003e\n \u003cp\u003e5 (4.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eSymptoms before catheter insertion\u003c/p\u003e\n \u003cp\u003eDyspnea\u003c/p\u003e\n \u003cp\u003eLack of appetite\u003c/p\u003e\n \u003cp\u003eConstipation\u003c/p\u003e\n \u003cp\u003ePain\u003c/p\u003e\n \u003cp\u003eFilling full quickly after eating\u003c/p\u003e\n \u003cp\u003eAbdominal discomfort\u003c/p\u003e\n \u003cp\u003eVomiting\u003c/p\u003e\n \u003cp\u003eNausea\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e73 (64.6%)\u003c/p\u003e\n \u003cp\u003e81 (71.1%)\u003c/p\u003e\n \u003cp\u003e13 (11.5%)\u003c/p\u003e\n \u003cp\u003e68 (60.2%)\u003c/p\u003e\n \u003cp\u003e74 (65.5%)\u003c/p\u003e\n \u003cp\u003e89 (78.8%)\u003c/p\u003e\n \u003cp\u003e23 (20.4%)\u003c/p\u003e\n \u003cp\u003e52 (46.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003ePrevious paracentesis performed (within previous 3 months)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e32 (28.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003ePrevious oncological treatment (any time in the past):\u003c/p\u003e\n \u003cp\u003eSurgery\u003c/p\u003e\n \u003cp\u003eChemotherapy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e20 (17.7%)\u003c/p\u003e\n \u003cp\u003e21 (18.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e* ECOG, Eastern Cooperative Oncology Group\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2. Number of enrolled patients per site.\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"45.97457627118644%\" valign=\"top\"\u003e\n \u003cp\u003eInstitution\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.059322033898304%\" valign=\"top\"\u003e\n \u003cp\u003eCountry\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.966101694915253%\" valign=\"top\"\u003e\n \u003cp\u003ePatients enrolled\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"45.97457627118644%\" valign=\"top\"\u003e\n \u003cp\u003eWroclaw Oncology Center\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.059322033898304%\" valign=\"top\"\u003e\n \u003cp\u003ePoland\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.966101694915253%\" valign=\"top\"\u003e\n \u003cp\u003e57\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"45.97457627118644%\" valign=\"top\"\u003e\n \u003cp\u003eGdynia Oncology Center\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.059322033898304%\" valign=\"top\"\u003e\n \u003cp\u003ePoland\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.966101694915253%\" valign=\"top\"\u003e\n \u003cp\u003e30\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"45.97457627118644%\" valign=\"top\"\u003e\n \u003cp\u003eUMC Maribor\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.059322033898304%\" valign=\"top\"\u003e\n \u003cp\u003eSlovenia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.966101694915253%\" valign=\"top\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"45.97457627118644%\" valign=\"top\"\u003e\n \u003cp\u003eUH Ostrava\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.059322033898304%\" valign=\"top\"\u003e\n \u003cp\u003eCzech Republic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.966101694915253%\" valign=\"top\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"45.97457627118644%\" valign=\"top\"\u003e\n \u003cp\u003eUH Hradec Kr\u0026aacute;lov\u0026eacute;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.059322033898304%\" valign=\"top\"\u003e\n \u003cp\u003eCzech Republic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.966101694915253%\" valign=\"top\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 3. Indications and procedural issues of catheter insertion and drainage.\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eIndications for ascites drainage (can be more than one):\u003c/p\u003e\n \u003cp\u003eSymptoms control\u003c/p\u003e\n \u003cp\u003eSupportive to oncological treatment\u003c/p\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e110 (97.3%)\u003c/p\u003e\n \u003cp\u003e59 (52.2%)\u003c/p\u003e\n \u003cp\u003e3 (2.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eAnesthesia for catheter insertion\u003c/p\u003e\n \u003cp\u003eLocal\u003c/p\u003e\n \u003cp\u003eSedation\u003c/p\u003e\n \u003cp\u003eGeneral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e105 (92.9%)\u003c/p\u003e\n \u003cp\u003e8 (7.1%)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eCatheter replacement at the time of first insertion required\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e1 (0.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eCatheter replacement later (during drainage)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e6 (5.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eLobulated ascites at the time of first catheter insertion\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e24 (21.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eVolume of ascites evacuated at the catheter insertion [median (range), ml]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e2000 (0-5000)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003eVolume of ascites evacuated weekly [median (range), ml]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e7000 (500-15000)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"75%\" valign=\"top\"\u003e\n \u003cp\u003ePatient controlling symptoms and satisfied from the procedure \u0026ndash; general impression of patient as answered to physician\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25%\" valign=\"top\"\u003e\n \u003cp\u003e95 (84.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eIndications and issues concerned with catheter insertion and drainage follow-up are presented in Table 3.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEight adverse events were detected in 7 patients (6.2%), including one serious adverse event. One patient died 9 days after the catheter insertion. We found no direct relationship between intervention and death. Patients was readmitted to the hospital 3 days after catheter insertion, and deteriorated each day, independently of medical tests and interventions. Peritonitis was excluded. The patient was 70 years old, her primary malignancy was pancreatic cancer, she had no significant co-morbidities, her BMI was 24 kg/m2, she was estimated as PS-1 before catheter insertion, and the procedure was done for palliation only. The median volume of drained ascites was 2000 ml just after the catheter insertion, and 3500 ml during the next 7 days. All other adverse events are presented in Table 4. These were resolved after appropriate management. For the local infection of subcutaneous tissue oral antibiotics were prescribed. For obstructed catheters, their removal was necessary, and the successful insertion of new ones was performed. For self-removal, new catheters were inserted if still needed. For nausea, antimimetics were effective. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 4. Adverse events and patients\u0026rsquo; characteristics.\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"690\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"6.531204644412192%\" valign=\"top\"\u003e\n \u003cp\u003eCase\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.772133526850508%\" valign=\"top\"\u003e\n \u003cp\u003eAE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.304789550072568%\" valign=\"top\"\u003e\n \u003cp\u003eGrade (grading system)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.708272859216255%\" valign=\"top\"\u003e\n \u003cp\u003eTime since intervention [days]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eSAE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.030478955007258%\" valign=\"top\"\u003e\n \u003cp\u003ePrimary malignancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003ePS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.336719883889696%\" valign=\"top\"\u003e\n \u003cp\u003eCo-morbidities\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eBMI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"4.063860667634253%\" valign=\"top\"\u003e\n \u003cp\u003eT / P\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.57910014513788%\" valign=\"top\"\u003e\n \u003cp\u003eVolume drained\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"6.531204644412192%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.772133526850508%\" valign=\"top\"\u003e\n \u003cp\u003eInfection, local\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.304789550072568%\" valign=\"top\"\u003e\n \u003cp\u003eG2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.708272859216255%\" valign=\"top\"\u003e\n \u003cp\u003e16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e73\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.030478955007258%\" valign=\"top\"\u003e\n \u003cp\u003eovarian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.336719883889696%\" valign=\"top\"\u003e\n \u003cp\u003ehypertension\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003e32\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"4.063860667634253%\" valign=\"top\"\u003e\n \u003cp\u003eT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.57910014513788%\" valign=\"top\"\u003e\n \u003cp\u003e1500/c\u003c/p\u003e\n \u003cp\u003e700/w\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"6.531204644412192%\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.772133526850508%\" valign=\"top\"\u003e\n \u003cp\u003eCatheter obstruction\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.304789550072568%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.708272859216255%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e70\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.030478955007258%\" valign=\"top\"\u003e\n \u003cp\u003eovarian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.336719883889696%\" valign=\"top\"\u003e\n \u003cp\u003eRectal and breast cancers in anamnesis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003e27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"4.063860667634253%\" valign=\"top\"\u003e\n \u003cp\u003eT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.57910014513788%\" valign=\"top\"\u003e\n \u003cp\u003e700/c\u003c/p\u003e\n \u003cp\u003e2500/w\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"6.531204644412192%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.772133526850508%\" valign=\"top\"\u003e\n \u003cp\u003eSelf-removal of the catheter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.304789550072568%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.708272859216255%\" valign=\"top\"\u003e\n \u003cp\u003e73\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e79\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.030478955007258%\" valign=\"top\"\u003e\n \u003cp\u003eovarian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.336719883889696%\" valign=\"top\"\u003e\n \u003cp\u003eCoronary disease\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003e44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"4.063860667634253%\" valign=\"top\"\u003e\n \u003cp\u003eP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.57910014513788%\" valign=\"top\"\u003e\n \u003cp\u003e1000/c\u003c/p\u003e\n \u003cp\u003e5000/w\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"6.531204644412192%\" valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.772133526850508%\" valign=\"top\"\u003e\n \u003cp\u003eNausea\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.304789550072568%\" valign=\"top\"\u003e\n \u003cp\u003e?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.708272859216255%\" valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e58\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.030478955007258%\" valign=\"top\"\u003e\n \u003cp\u003eovarian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.336719883889696%\" valign=\"top\"\u003e\n \u003cp\u003eHypertension\u003c/p\u003e\n \u003cp\u003eHyperlipidemia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003e41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"4.063860667634253%\" valign=\"top\"\u003e\n \u003cp\u003eT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.57910014513788%\" valign=\"top\"\u003e\n \u003cp\u003e500/c\u003c/p\u003e\n \u003cp\u003e4000/w\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"6.531204644412192%\" valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.772133526850508%\" valign=\"top\"\u003e\n \u003cp\u003eSelf-removal of the catheter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.304789550072568%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.708272859216255%\" valign=\"top\"\u003e\n \u003cp\u003e27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e58\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.030478955007258%\" valign=\"top\"\u003e\n \u003cp\u003eovarian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.336719883889696%\" valign=\"top\"\u003e\n \u003cp\u003eHypertension\u003c/p\u003e\n \u003cp\u003eHyperlipidemia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003e41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"4.063860667634253%\" valign=\"top\"\u003e\n \u003cp\u003eT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.57910014513788%\" valign=\"top\"\u003e\n \u003cp\u003e500/c\u003c/p\u003e\n \u003cp\u003e4000/w\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"6.531204644412192%\" valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.772133526850508%\" valign=\"top\"\u003e\n \u003cp\u003eCatheter obstruction\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.304789550072568%\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.708272859216255%\" valign=\"top\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.030478955007258%\" valign=\"top\"\u003e\n \u003cp\u003eovarian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.336719883889696%\" valign=\"top\"\u003e\n \u003cp\u003eNone\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"4.063860667634253%\" valign=\"top\"\u003e\n \u003cp\u003eT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.57910014513788%\" valign=\"top\"\u003e\n \u003cp\u003e2000/c\u003c/p\u003e\n \u003cp\u003e5000/w\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"6.531204644412192%\" valign=\"top\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.772133526850508%\" valign=\"top\"\u003e\n \u003cp\u003eInfection, local\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.304789550072568%\" valign=\"top\"\u003e\n \u003cp\u003eG2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.708272859216255%\" valign=\"top\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e68\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.030478955007258%\" valign=\"top\"\u003e\n \u003cp\u003eendometrial\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"5.515239477503629%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.336719883889696%\" valign=\"top\"\u003e\n \u003cp\u003eHypertension\u003c/p\u003e\n \u003cp\u003eAtrial flutter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"6.821480406386066%\" valign=\"top\"\u003e\n \u003cp\u003e33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"4.063860667634253%\" valign=\"top\"\u003e\n \u003cp\u003eP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.57910014513788%\" valign=\"top\"\u003e\n \u003cp\u003e2000/c\u003c/p\u003e\n \u003cp\u003e3000/w\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAbbreviation: /c, volume of drained ascites just after catheter insertion; /w, volume of drained ascites per week; AE, adverse event; P, palliation (no oncological treatment); PS, performance status (at the time of catheter insertion); SAE, serious adverse event; T, active oncological treatment\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eQOL was measured based on 112 completed questionnaires before insertion of the catheter and 10-14 days after/ during drainage. Detailed data on changes in QOL are provided in Table 5. During the ascites drainage, with the catheter in situ, versus the state without catheter (before drainage), we found significantly better global QOL (mean 47.8 vs 31.8), improvement in physical (64.4 vs 52.6) and emotional functioning (65.4 vs 50.7). All symptoms evaluated in the questionnaire were significantly less noticeable: fatigue (50.9 vs 66.7), nausea and vomiting (21.4 vs 37.8), pain (34.1 vs 53.9), dyspnea (22.3 vs 48.5), insomnia (34.3 vs 49.1), appetite loss (40.3 vs 56.3) and constipation (25.2 vs 31.0). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 5. Changes in quality of life, based on the QLQ-C15-PAL questionnaire, before and after/during the ascites drainage with the catheter in situ.\u0026nbsp;\u003c/p\u003e\n\u003cdiv align=\"center\"\u003e\n \u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\"\u003e\n \u003cp\u003e\u003cstrong\u003eBefore\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n=112)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\"\u003e\n \u003cp\u003e\u003cstrong\u003eAfter / during\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n=112)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eP\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQuality of life (global) (QL)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"bottom\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.000001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e31.8 (19.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e47.8 (20.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-83.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-83.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e50.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[28.3;35.4]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[43.8;51.8]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e16.7, 41.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003ePhysical functioning (PF)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.000001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e52.6 (24.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e64.4 (22.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e55.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[48.0;57.1]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[60.0;68.7]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e55.6, 77.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eEmotional functioning (EF)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.000001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e50.7 (28.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e65.4 (22.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e50.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[45.5;56.0]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[61.1;69.7]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e50.0, 83.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eFatigue (FA)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.000001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e66.7 (25.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e50.9 (23.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e16.7-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e50.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[62.0;71.4]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[46.4;55.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e50.0, 83.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eNausea and vomiting (NV)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e37.8 (35.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e21.4 (28.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[31.2;44.4]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[15.8;26.9]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0, 33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003ePain (PA)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"bottom\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.000001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e53.9 (31.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e34.1 (25.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[47.9;59.8]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[29.3;39.0]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3, 83,3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e16.7, 50.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eDyspnea\u0026nbsp;(DY)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.000001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e48.5 (31.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e22.6 (22.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[42.7;54.4]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[18.3;26.9]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0, 33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eInsomnia\u0026nbsp;(SL)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e49.1 (31.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e34.3 (27.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[43.2;55.0]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[29.1;39.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eAppetite loss\u0026nbsp;(AP)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0001\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e56.3 (32.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e40.3 (32.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[50.1;62.4]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[34.1;46.4]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eConstipation\u0026nbsp;(CO)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0072\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e112\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e106\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emean. (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e31.0 (34.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e25.2 (27.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003erange\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0-100.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003emedian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003e95%CI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[24.4;37.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e[19.9;30.5]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.36363636363637%\" valign=\"top\"\u003e\n \u003cp\u003eQ1, Q3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0, 66.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e0.0, 33.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003eWilcoxon test \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring the period of the first evaluation (10 \u0026ndash; 14 days of drainage), we did not see significant changes in the type of diet that patients reported, nor did we note any changes in the SGA general rating. However, during the ascites drainage, with the catheter in situ, versus the state without the catheter (before drainage), significantly more patients had no pain on eating (82.9% vs 71.3%, p=0.04), no nausea (66.0% vs 47.3%, p=0.005) (1.9% experienced severe nausea during the drainage versus 15.5% before catheter insertion, p\u0026lt;0,001), no vomiting (89.5% vs 74.3%, p=0,004), no diarrhea (93.3% vs 81.5%, p=0,009).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOf note is that none of the patients had to come for repeated paracentesis, but those who had their catheter obstructed (re-insertion). All of them were able to drain their ascites alone, at home.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAccording to the results of the FACIT-TS-G questionnaire, 78% were satisfied with the intervention completely or for the most part, 83% would recommend the procedure to others with the same condition, and 90% would again undergo ascites drainage with the catheter if they needed it. Details are provided in Table 6.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 6. Selected results of the FACIT-TS-G questionnaire \u0026ndash; after/during drainage: patients experience with drainage via the central venous catheter inserted into the abdominal cavity (N=105).\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eNo, not at\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eall\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes, to\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003esome\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eextent\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes, for\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ethe most\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003epart\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes,\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ecompletely\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDo you feel you received the treatment that was right for you?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e16%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e49%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e35%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAre you satisfied with the effects of this\u003c/p\u003e\n \u003cp\u003etreatment so far?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e22%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e48%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e30%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eNo\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMaybe\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWould you recommend this treatment to others with your illness?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e17%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e83%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWould you choose this treatment again?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e9%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e90%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePoor\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFair\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eGood\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eVery\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eGood\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eExcellent\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eHow do you rate this treatment overall?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e44%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e45%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e10%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Discussion","content":"\u003cp\u003eDrainage of symptomatic MA via CVC was safe, provided improvements in some functional QOL scales, diminished all evaluated symptoms, and was positively assessed by patients who had undergone the intervention. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSafety\u003c/p\u003e\n\u003cp\u003eIn a systematic review, generally, 19.7% (255/1297) of patients experienced any complication and 6.2% (81/1297) experienced serious adverse events (SAE) during MA drainage. The rate of complications was different for different drainage methods. After paracentesis for various malignancies, the rate of complications was: 0%\u0026ndash;8% (SAE: 0%\u0026ndash;5%); drainage using a CVC: 9%\u0026ndash;25% (SAE: 0%); permanent peritoneal port: 4%\u0026ndash;79% (SAE 0%\u0026ndash;4%); tunneled peritoneal catheters: 8%\u0026ndash;56% (SAE 0%\u0026ndash;39%); for PleurX: 8%\u0026ndash;56% (SAE 0%\u0026ndash;12%); for Tenckhoff: 9%\u0026ndash;29% (SAE 0%); and peritoneovenous shunts: 26%\u0026ndash;55% (SAE 5%\u0026ndash;33%). The most serious procedure-related complications were reported for peritoneovenous shunts (mortality from pulmonary edema and thromboembolism)\u0026nbsp;[1]. Later published data generally confirmed a relatively safe profile of MA drainage with paracentesis and drains\u0026nbsp;[9-12]. However, some details need attention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOne-time insertion of a permanent catheter (also vascular catheter) into the abdominal cavity should be performed under ultrasound control to minimize the risk of potential injuries (bowel, vascular, other) related to the procedure of insertion. If done without imaging control can end with fatal bowel perforation (1% of a cohort undergoing drainage) [11].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePeritonitis is one of the most significant and serious adverse events of prolonged ascites drainage via permanent catheters [1]. Also, in more recent publications peritonitis is still an important issue, that is reported with different frequencies: 1% with paracentesis / indwelling catheter (pigtail) [11]; 2% with the usage of the peritoneal catheter [10], however information on the outcome of the complication is lacking in both cited studies. There were 4.4% peritonitis (6/137) complications after drainage of ascites via a tunneled peritoneal catheter (PleurX, 19-gauge), and one catheter-associated death (bacterial peritonitis; 0.8%) [12]. In another study, where tunneled indwelling peritoneal catheters were placed for the management of recurrent MA in 48 patients, the rate of bacterial peritonitis was as high as 8.8%, with all patients responding to antibiotics and only one required catheter removal [13]. Chen et al reported retrospectively on outcomes of 26 patients with inserted tunneled intraperitoneal ports (subcutaneous). Interestingly, the mean number of times each port was accessed was 10 (range: 1\u0026ndash;90), which was possible at patients\u0026rsquo; homes too, so prevented repeated paracentesis. However, reported rates of cellulitis and peritonitis were 7% and 12% per patient and per port, respectively. Unfortunately, the authors did not provide management and outcomes of peritonitis [9]. It seems that either there must be some additional risk factors that peritonitis may become lethal (e.g. performance status, end-stage malignancy), or there are different definitions of peritonitis. An example of a very broad peritonitis definition was used by Chen et al: peritonitis was defined by abdominal pain or fever with ascites and an absolute neutrophil count greater than 250 cells per microlitre and/or positive ascites fluid or blood culture [9]. Of note is one study because its results differ from others [14]. In a retrospective, observational study, bacterial colonization of the catheter without immediate infection was noted after a mean time of 18 days in 69 of 143 patients following catheter insertion (43,5%). After a median of 14.5 days, thirty patients developed drain-related infection, accounting for 43.5% of those with prior positive bacterial colonization of the drain and 21% of all patients. Among those (n=69), 5 (7,2%) developed drain-related peritonitis, and 4 died from the infection (80% of deaths after the diagnosis of peritonitis, and 13.3% of deaths among all patients who developed drain-related infection). Other forms of infection were defined as drain-site cellulitis (20%), infected ascitic fluid without clinical features of peritonitis (26.7%), fever or sepsis without other demonstrable foci (10%), and physician-diagnosed drain-related infection (36.7%) [14]. One must note that the frequency of infection complications was higher in the Chan et al. group as compared to previously reported (0 \u0026ndash; 1.9% for G2 infections, and 0 \u0026ndash; 5.7% for G3 infections) [1]. Notably, one-third of the patients had hepatocellular carcinoma (HCC), and 27.5% of the patients had comorbid liver cirrhosis, and the multivariate analysis revealed that HCC [odds ratio (OR): 8.85; 95% confidence interval (CI): 1.86\u0026ndash;42.07, P=0.006] and decrease in body weight (OR: 1.20; 95% CI: 1.02\u0026ndash;1.42, P=0.03) were the only risk factors for developing infection complications [14]. The probable explanation for the higher risk and incidence of ascitic fluid infection among patients with liver failure was described elsewhere [15]. The risk of peritonitis during ascites drainage was higher in patients with end-stage liver disease (8.3%) [16] than in those with other malignancies (2.5%) [17]. Based on the research discussed herein, we should acknowledge a difference in the risk of infection during ascites drainage, between patients with ascites secondary to massive liver involvement (e.g., HCC, liver metastases) versus peritoneal carcinomatosis. These patients should probably be independently analyzed in future research studies [18], however, it is debatable [19].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe larger the diameter of a catheter, the more risk of complications, including infections\u0026nbsp;[20]. Dedicated peritoneal catheters (e.g. PleurX) have larger diameters (5.2 mm)\u0026nbsp;[10], than vascular catheters (2.2 mm) inserted into the abdominal cavity\u0026nbsp;[21]. Also, the longer catheter dwell time the higher the risk of infectious complications\u0026nbsp;[12].\u003c/p\u003e\n\u003cp\u003eHyponatremia is another possible complication of prolonged MA drainage, however it may not have clinical significance, because it is often untreated or unrecognized. Nevertheless, a risk group of patients with hepatopancreatobiliary malignancy and hyponatremia before drainage was suggested for routine testing of plasma sodium concentration, because hyponatremia may have significant negative implications\u0026nbsp;[22]. In another study sodium values declined both pre- and post-procedure (tunneled catheter insertion followed by drainage); the slope of decline diminished postprocedure compared with pre-procedure (sodium slope [\u0026ndash;2.50 to 1.31 mEq/L, p = 0.037]). No clinical relevance of the laboratory results was provided\u0026nbsp;[23].\u003c/p\u003e\n\u003cp\u003eLoculation of ascites is another complication that can happen in 2% of patients\u0026nbsp;[13]\u0026nbsp;after prolonged drainage, or repeated paracentesis. It needs to be addressed because no single drain can solve the problem\u003cem\u003e.\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIt seems that the variability in mean arterial pressure during drainage of MA is not dependent on drainage volume (two groups were compared: drainage of large (5-10 L) vs small (\u0026lt;5 L) volume) [24]. However, the \u0026ldquo;drainage to dryness\u0026rdquo; should not be the aim. It was shown that even small-volume (1.5-2.5 L) paracentesis could alleviate abdominal distension of terminally ill cancer patients with MA without shortening the paracentesis interval compared with moderate-volume (\u0026gt;2.5 L) paracentesis. Only drainage of a minimal volume (\u0026lt;1.5 L) was the risk factor (HR: 2.34) for a shorter interval to the next paracentesis [25]. In the case of permanently placed drains/catheters, the repeating paracentesis is not the case. Thus, the ascites drainage volume should rather be adapted to individual patients, with the main aim of controlling symptoms and improving QOL. Additionally, in one study it was shown that the median mass of MA was 3 240 \u0026ndash; 3 480 g, with a maximum as high as 14 350 g [26], thus evacuation of ascites may increase a patient\u0026rsquo;s mobility.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eQOL\u003c/p\u003e\n\u003cp\u003eQOL measured with EORTC QLQ-C30 before paracentesis for MA revealed that global QOL and emotional functioning were worse in patients with MA\u0026nbsp;[26]\u0026nbsp;as compared to a reference of all cancer patients\u0026nbsp;[27]\u0026nbsp;(38.9-41.1 vs 61.3 and 56.3-61.6 vs 71.4, respectively). Also, symptoms were more severe among patients with MA\u0026nbsp;[26]\u0026nbsp;than the reference\u0026nbsp;[27]\u0026nbsp;(24.7-63.4 vs 9.1-34.6)\u0026nbsp;\u003cem\u003e[26]\u003c/em\u003e\u003cem\u003e.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eQOL before and after drainage can be measured with simple scales. In a small retrospective study (n=30), on a 10-point scale, QOL compared to that before subcutaneous peritoneal and pleural port catheter placement, improvement was rated a mean of 9.5 by patients and 9.0 by the nursing staff. Both patients and nurses reported a high degree of convenience (rated at 9.7 and 9.6, respectively) and improvement of symptoms and comfort (9.6 and 9.3, respectively)\u0026nbsp;[28].\u003c/p\u003e\n\u003cp\u003eIn a prospective, longitudinal study of patients with refractory ascites associated with stage IV or end-stage malignancy who underwent percutaneous tunneled catheters (Tenckhoff) insertion in interventional radiology at a single institution, QOL was tested with EORTC QLQ-C30 and McGill QOL questionnaires, prior the procedure (n=47) and at 1 (n=37) and 3 (n=20) weeks during the drainage. A significant improvement was demonstrated in global QOL, functional role, emotional, and cognitive scales at 1 week. Also, significant symptom improvement was seen in fatigue, nausea/vomiting, pain, dyspnea, insomnia, and appetite loss. This improvement was sustained at 3 weeks for dyspnea, insomnia, and appetite [23].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn a longitudinal study that captured patient responses on selected symptoms and QOL instruments immediately before and 24 h after paracentesis for symptomatic ascites, it was shown that the evacuation of the fluid significantly improved mobility, appetite, decreased shortness of breath, fatigue, and level of anxiety and depression. It also improved role functioning, however had no impact on global QOL nor the social and physical functioning, and caused worse cognitive functioning\u0026nbsp;[4].\u003c/p\u003e\n\u003cp\u003eEasson et al. evaluated the measurement properties of selected existing validated symptom and QOL questionnaires in patients undergoing paracentesis for symptomatic ascites. They tested 4 different questionnaires and suggested that the EORTC QLQ-C30 and the ESAS:AM (Edmonton Symptom Assessment System\u0026ndash;Ascites Modification) together, or the QLQ-C30 with the addition of the QLQ-PAN26 (EORTC 26-item pancreatic cancer module) ascites and abdominal pain subscales could be used [29]. However, these questionnaires are complex and may not be suitable for many patients suffering symptoms of ascites and advanced malignancy. According to our observations, most patients are reluctant to concentrate on reading, understanding, and completing complex questionnaires. Their primary goal is to handle symptoms and they often face anxiety and depression. Thus, if completed under pressure, the results of complex questionnaires may be significantly biased. That is why we decided to use the shortest and easiest possible validated tools to assess QOL changes.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOthers measured changes in QOL by a systematic telephone review focusing on ascites-associated symptoms (using a five-point scale). The abdominal discomfort, impaired mobility, dyspnea, fatigue, nausea, and vomiting were significantly reduced 30 days after PleurX (tunneled, permanent drain) insertion (p\u0026lt;0.05) [10].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOther considerations\u003c/p\u003e\n\u003cp\u003eIn a palliative setting, median survival after drain insertion was 19 days (one-third survived less than 2 weeks). Thus, Murray et al suggested that in cases with symptomatic ascites, insertion of drains and drainage should not be delayed\u0026nbsp;[3]. Contrary, in the study by Wimberger et al. QOL of patients undergoing repeated paracentesis for MA were tested for up to 7 months (no data on overall survival). Importantly, half of the patients had ovarian cancer in this trial\u0026nbsp;[26]. In another cohort, median survival was 38 days after placement of tunneled drainage catheters (ovarian cancer constituted 18.8%)\u0026nbsp;[23]. Thus, the timing of catheter insertion for permanent ascites drainage should be individually considered and not delayed for symptomatic patients. It is even more important if larger procedures, like tunneled catheter implantation, are planned. As suggested by Korpi et al., patients with ascites secondary to advanced pancreatic cancer may as well benefit from repeated paracentesis, instead of being subjected to more invasive procedures like insertion of larger catheters\u0026nbsp;[30]. Of note is that smaller catheters, like the CVC, can be easily inserted, even in an ambulatory setting as shown in our study and the previous ones\u0026nbsp;[21, 31, 32].\u003c/p\u003e\n\u003cp\u003eAnother issue is the economy. According to research by Wu et al. tunneled peritoneal catheter was the most cost-effective strategy when compared to repeated large-volume paracentesis in patients with recurrent ascites from gynecological malignancy [33]. Even more significant economic benefit may be expected if CVC was used because the procedure of insertion is much easier than it is for tunneled catheters. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe limitations of our study include the population of patients with MA, among which ovarian cancer patients were the most frequent, results are based on prerequisite data collection tools, and the main settings of recruiting institutions were cancer centers (not palliative departments) and thus our results may not be generalized to all clinical settings.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eMA drainage via patient-controlled CVC inserted into the abdominal cavity is safe and improves patients\u0026rsquo; QOL. It can be considered supportive management, whenever required, from the moment of diagnosis until the end-life stage. The research is ongoing with more institutions involved. Thus, we expect to provide robust data on a larger patient cohort.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eDisclosures and declarations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no relevant financial or non-financial interests to disclose.\u003c/p\u003e\n\u003cp\u003eThere was no funding. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMaciej Stukan, David Cibula, and Radosław Mądry contributed to the study conception and design. Material preparation and data collection were done by Marcin Jędryka, Andrej Cokan, Jaroslav Klat, Munachiso Ndukwe Iheme Jr., Marcin Kryszpin, Renata Pobłocka, Eva Timo\u0026scaron;ek, Martina Romanov\u0026aacute;, Kl\u0026aacute;ra Kolařov\u0026aacute;. Analysis of data was performed by Maciej Stukan. The first draft of the manuscript was written by Maciej Stukan and all authors could have commented on previous versions of the manuscript. All authors read and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eThis study was performed in line with the principles of the Declaration of Helsinki.\u003c/em\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003eEthical Committee by Medical Council in Gdansk, Poland approved the study protocol and its amendments (KB 17/15, KB 18/16, KB 15/17, KB 16/20), and additional local approvals were obtained by each participating center. \u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eData repository\u0026nbsp;\u003c/h4\u003e\n\u003cp\u003eThe database of this study is not publicly available. Interested researchers who provide a methodologically sound proposal can access de-identified data.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eStukan M (2017) Drainage of malignant ascites: patient selection and perspectives. Cancer Manag Res 9:115\u0026ndash;130. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2147/cmar.S100210\u003c/span\u003e\u003cspan address=\"10.2147/cmar.S100210\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHui D, Bruera E (2016) Integrating palliative care into the trajectory of cancer care. Nature reviews Clinical oncology 13 (3):159\u0026ndash;171. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1038/nrclinonc.2015.201\u003c/span\u003e\u003cspan address=\"10.1038/nrclinonc.2015.201\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMurray FR, Gnehm F, Schindler V, Morell B, Gubler C, Kretschmer EM, B\u0026uuml;tikofer S (2022) Permanent Tunneled Drainage of Ascites in Palliative Patients: Timing Needs Evaluation. J Palliat Med 25 (7):1132\u0026ndash;1135. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1089/jpm.2021.0506\u003c/span\u003e\u003cspan address=\"10.1089/jpm.2021.0506\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHusain A, Bezjak A, Easson A (2010) Malignant ascites symptom cluster in patients referred for paracentesis. Ann Surg Oncol 17 (2):461\u0026ndash;469. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1245/s10434-009-0774-0\u003c/span\u003e\u003cspan address=\"10.1245/s10434-009-0774-0\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGroenvold M, Petersen MA, Aaronson NK, Arraras JI, Blazeby JM, Bottomley A, Fayers PM, de Graeff A, Hammerlid E, Kaasa S, Sprangers MA, Bjorner JB (2006) The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. European journal of cancer (Oxford, England: 1990) 42 (1):55\u0026ndash;64. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ejca.2005.06.022\u003c/span\u003e\u003cspan address=\"10.1016/j.ejca.2005.06.022\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDuerksen DR, Laporte M, Jeejeebhoy K (2021) Evaluation of Nutrition Status Using the Subjective Global Assessment: Malnutrition, Cachexia, and Sarcopenia. Nutr Clin Pract 36 (5):942\u0026ndash;956. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1002/ncp.10613\u003c/span\u003e\u003cspan address=\"10.1002/ncp.10613\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePeipert JD, Beaumont JL, Bode R, Cella D, Garcia SF, Hahn EA (2014) Development and validation of the functional assessment of chronic illness therapy treatment satisfaction (FACIT TS) measures. Qual Life Res 23 (3):815\u0026ndash;824. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s11136-013-0520-8\u003c/span\u003e\u003cspan address=\"10.1007/s11136-013-0520-8\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCharlson ME, Pompei P, Ales KL, MacKenzie CR (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. Journal of chronic diseases 40 (5):373\u0026ndash;383. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/0021-9681(87)90171-8\u003c/span\u003e\u003cspan address=\"10.1016/0021-9681(87)90171-8\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChen BS, Wong SHC, Hawkins S, Huggins L (2018) Permanent peritoneal ports for the management of recurrent malignant ascites: a retrospective review of safety and efficacy. Intern Med J 48 (12):1524\u0026ndash;1528. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/imj.14137\u003c/span\u003e\u003cspan address=\"10.1111/imj.14137\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePetzold G, Bremer SCB, Heuschert FC, Treiber H, Ellenrieder V, Kunsch S, Neesse A (2021) Tunnelled Peritoneal Catheter for Malignant Ascites-An Open-Label, Prospective, Observational Trial. Cancers (Basel) 13 (12). doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3390/cancers13122926\u003c/span\u003e\u003cspan address=\"10.3390/cancers13122926\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSeah DS, Wilcock A, Chang S, Sousa MS, Sinnarajah A, Teoh CO, Allan S, Chye R, Doogue M, Hunt J, Agar M, Currow DC (2022) Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study. Palliative medicine 36 (9):1408\u0026ndash;1417. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1177/02692163221122326\u003c/span\u003e\u003cspan address=\"10.1177/02692163221122326\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKnight JA, Thompson SM, Fleming CJ, Bendel EC, Neisen MJ, Neidert NB, Stockland AH, Bjarnason H, Woodrum DA (2018) Safety and Effectiveness of Palliative Tunneled Peritoneal Drainage Catheters in the Management of Refractory Malignant and Non-malignant Ascites. Cardiovascular and interventional radiology 41 (5):753\u0026ndash;761. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s00270-017-1872-1\u003c/span\u003e\u003cspan address=\"10.1007/s00270-017-1872-1\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan KP, Badiei A, Tan CPS, Fitzgerald DB, Stanley C, Fysh ETH, Shrestha R, Muruganandan S, Read CA, Thomas R, Lee YCG (2020) Use of indwelling pleural/peritoneal catheter in the management of malignant ascites: a retrospective study of 48 patients. Intern Med J 50 (6):705\u0026ndash;711. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/imj.14642\u003c/span\u003e\u003cspan address=\"10.1111/imj.14642\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan PC, Cheung KWA, Chan CH, Hwang LM, Lo SH (2020) Patterns and infection outcomes of bacterial colonization in patients with indwelling abdominal drains for malignant ascites. Annals of palliative medicine 9 (6):4490\u0026ndash;4501. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.21037/apm.2019.09.15\u003c/span\u003e\u003cspan address=\"10.21037/apm.2019.09.15\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePiano S, Tonon M, Angeli P (2018) Management of ascites and hepatorenal syndrome. Hepatology International 12 (1):122\u0026ndash;134. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s12072-017-9815-0\u003c/span\u003e\u003cspan address=\"10.1007/s12072-017-9815-0\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSolbach P, H\u0026ouml;ner Zu Siederdissen C, Taubert R, Ziegert S, Port K, Schneider A, Hueper K, Manns MP, Wedemeyer H, Jaeckel E (2017) Home-based drainage of refractory ascites by a permanent-tunneled peritoneal catheter can safely replace large-volume paracentesis. Eur J Gastroenterol Hepatol 29 (5):539\u0026ndash;546. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/meg.0000000000000837\u003c/span\u003e\u003cspan address=\"10.1097/meg.0000000000000837\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWong BCT, Cake L, Kachuik L, Amjadi K (2015) Indwelling Peritoneal Catheters for Managing Malignancy-Associated Ascites. Journal of Palliative Care 31 (4):243\u0026ndash;249. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1177/082585971503100406\u003c/span\u003e\u003cspan address=\"10.1177/082585971503100406\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStukan M (2020) Malignant ascites drainage with indwelling abdominal catheters: can we predict and prevent infection complication? Annals of palliative medicine 9 (2):136\u0026ndash;140. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.21037/apm.2019.11.29\u003c/span\u003e\u003cspan address=\"10.21037/apm.2019.11.29\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAujayeb A, Jackson K (2020) Infection in indwelling peritoneal catheters for malignant ascites. Annals of palliative medicine 9 (3):1280\u0026ndash;1281. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.21037/apm.2020.03.11\u003c/span\u003e\u003cspan address=\"10.21037/apm.2020.03.11\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eT\u0026uuml;rk Y, Devecioğlu İ, Yıldızhan İ, Arslan BC, Arıbaş BK (2022) Tunneled Uncuffed Pigtail Drainage Catheter Placement in Patients with Refractory Ascites or Pleural Effusion: A Single-Center Experience. Cardiovascular and interventional radiology 45 (11):1735\u0026ndash;1741. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s00270-022-03248-2\u003c/span\u003e\u003cspan address=\"10.1007/s00270-022-03248-2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStukan M, Lesniewski-Kmak K, Wroblewska M, Dudziak M (2015) Management of symptomatic ascites and post-operative lymphocysts with an easy-to-use, patient-controlled, vascular catheter. Gynecologic oncology 136 (3):466\u0026ndash;471. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ygyno.2014.11.073\u003c/span\u003e\u003cspan address=\"10.1016/j.ygyno.2014.11.073\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGupta S, Tio MC, Gutowski ED, Stecker MS, Verma A, Motwani SS, Mount DB, McMahon GM, Waikar SS (2020) Incidence of Hyponatremia in Patients With Indwelling Peritoneal Catheters for Drainage of Malignant Ascites. JAMA Netw Open 3 (10):e2017859. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1001/jamanetworkopen.2020.17859\u003c/span\u003e\u003cspan address=\"10.1001/jamanetworkopen.2020.17859\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRobson PC, Gonen M, Ni A, Brody L, Brown KT, Getrajdman G, Thom B, Kline N, Covey A (2019) Quality of life improves after palliative placement of percutaneous tunneled drainage catheter for refractory ascites in prospective study of patients with end-stage cancer. Palliat Support Care 17 (6):677\u0026ndash;685. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1017/s1478951519000051\u003c/span\u003e\u003cspan address=\"10.1017/s1478951519000051\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKawamura T, Tanaka N, Hori M, Inoue KI, Kawamura M, Matsusaki K (2023) Hemodynamic Variability During Drainage of Large Volumes of Malignant Ascites in Patients With Cancer. Clin Nurs Res 32 (4):815\u0026ndash;820. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1177/10547738231157157\u003c/span\u003e\u003cspan address=\"10.1177/10547738231157157\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIto T, Yokomichi N, Ishiki H, Kawaguchi T, Masuda K, Tsukuura H, Funaki H, Suzuki K, Oya K, Nakagawa J, Mori M, Yamaguchi T (2021) Optimal Paracentesis Volume for Terminally Ill Cancer Patients With Ascites. Journal of pain and symptom management 62 (5):968\u0026ndash;977. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jpainsymman.2021.04.010\u003c/span\u003e\u003cspan address=\"10.1016/j.jpainsymman.2021.04.010\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWimberger P, Gilet H, Gonschior AK, Heiss MM, Moehler M, Oskay-Oezcelik G, Al-Batran SE, Schmalfeldt B, Schmittel A, Schulze E, Parsons SL (2012) Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone. Annals of oncology: official journal of the European Society for Medical Oncology / ESMO 23 (8):1979\u0026ndash;1985. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1093/annonc/mds178\u003c/span\u003e\u003cspan address=\"10.1093/annonc/mds178\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eScott N, Fayers P, Aaronson N, Bottomley A, de Graeff A, Groenvold M, Gundy C, Koller M, Petersen M, Sprangers M (2008) EORTC QLQ-C30 Reference Values.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMonsky WL, Yoneda KY, MacMillan J, Deutsch LS, Dong P, Hourigan H, Schwartz Y, Magee S, Duffield C, Boak T, Cernilia J (2009) Peritoneal and pleural ports for management of refractory ascites and pleural effusions: assessment of impact on patient quality of life and hospice/home nursing care. J Palliat Med 12 (9):811\u0026ndash;817. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1089/jpm.2009.0061\u003c/span\u003e\u003cspan address=\"10.1089/jpm.2009.0061\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEasson AM, Bezjak A, Ross S, Wright JG (2007) The ability of existing questionnaires to measure symptom change after paracentesis for symptomatic ascites. Ann Surg Oncol 14 (8):2348\u0026ndash;2357. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1245/s10434-007-9370-3\u003c/span\u003e\u003cspan address=\"10.1245/s10434-007-9370-3\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKorpi S, Salminen VV, Piili RP, Paunu N, Luukkaala T, Lehto JT (2018) Therapeutic Procedures for Malignant Ascites in a Palliative Care Outpatient Clinic. J Palliat Med 21 (6):836\u0026ndash;841. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1089/jpm.2017.0616\u003c/span\u003e\u003cspan address=\"10.1089/jpm.2017.0616\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMercadante S, Intravaia G, Ferrera P, Villari P, David F (2008) Peritoneal catheter for continuous drainage of ascites in advanced cancer patients. Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer 16 (8):975\u0026ndash;978. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s00520-008-0453-x\u003c/span\u003e\u003cspan address=\"10.1007/s00520-008-0453-x\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGu X, Zhang Y, Cheng M, Liu M, Zhang Z, Cheng W (2016) Management of non-ovarian cancer malignant ascites through indwelling catheter drainage. BMC Palliat Care 15:44. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1186/s12904-016-0116-5\u003c/span\u003e\u003cspan address=\"10.1186/s12904-016-0116-5\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWu X, Keller EJ, Rabei R, Rockwell H, Beeson S, Heller M, Kothary N (2022) Cost-effectiveness of tunneled peritoneal catheters versus repeat paracenteses for recurrent ascites in gynecologic malignancies. Gynecologic oncology 164 (3):639\u0026ndash;644. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ygyno.2022.01.011\u003c/span\u003e\u003cspan address=\"10.1016/j.ygyno.2022.01.011\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"supportive-care-in-cancer","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jscc","sideBox":"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)","snPcode":"520","submissionUrl":"https://submission.nature.com/new-submission/520/3","title":"Supportive Care in Cancer","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-4266210/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4266210/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"Malignant ascites (MA) and repeated paracentesis can impair patient’s quality of life (QOL).\nThe aim was to evaluate changes in patients’ QOL and the safety of MA drainage with a patient-controlled central vascular catheter (CVC) inserted into the abdominal cavity.\nThis is an interim analysis of a prospective, multicentre trial ongoing within the Central and Eastern European Gynaecologic Oncology Group (CEEGOG). CVC (14-Ga) was inserted into the abdominal cavity of patients with symptomatic MA and drainage was controlled by patients at home. The rate and quality of complications were classified according to Common Terminology Criteria for Adverse Events Version 5.0. QOL was evaluated before and 10-14 days after/during drainage with standardized QLQ-C15-PAL, SGA, and FACIT-TS-G questionnaires. Wilcoxon and Chi-squared tests were used.\nAmong 113 recruited patients (2015-2022) 8 adverse events were detected in 7 patients (6.2%), including one serious (death on the 9th day after catheter insertion, classified as not related to the intervention). Other complications were local infection (n=2) (resolved after oral antibiotics), catheter obstruction (n=2), catheter self-removal (n=2) (re-insertion performed), and nausea (n=1). When comparing the assessment before and after/during drainage, we found the significantly better global quality of life (mean 31.8 vs 47.8, p\u003c0.001), improvement in physical (52.6 vs 64.4, p\u003c0.001) and emotional functioning (50.7 vs 65.4, p\u003c0.001); symptoms were significantly less intense: fatigue (66.7 vs 50.9, p\u003c0.001), nausea and vomiting (37.8 vs 21.4, p\u003c0.001), pain (53.9 vs 34.1, p\u003c0.001), dyspnoea (48.5 vs 22.3, p\u003c0.001), insomnia (49.1 vs 34.3, p\u003c0.001), appetite loss (56.3 vs 40.3, p\u003c0.001), constipation (31.0 vs 25.2, p=0.007), and more patients had no pain on eating (71.3% vs 82.9%, p=0.04). Most patients (78%) were satisfied, 83% would recommend the procedure to others, and 90% would choose intervention again.\nMA drainage via patient-controlled CVC inserted into the abdominal cavity is safe and improves patients’ QOL.","manuscriptTitle":"Symptomatic Malignant Ascites Drainage with a Patient-controlled Vascular Catheter – interim analysis of safety and patients’ reported outcomes","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-02 13:22:02","doi":"10.21203/rs.3.rs-4266210/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-12-28T14:07:51+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-22T05:46:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"310068421937559775427853057127206702882","date":"2024-06-27T23:55:01+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-05-28T18:35:37+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-05-28T18:32:36+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-04-26T02:11:58+00:00","index":"","fulltext":""},{"type":"submitted","content":"Supportive Care in Cancer","date":"2024-04-14T20:09:10+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"supportive-care-in-cancer","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jscc","sideBox":"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)","snPcode":"520","submissionUrl":"https://submission.nature.com/new-submission/520/3","title":"Supportive Care in Cancer","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"2825cd93-bb87-4ab7-baeb-797bfe489735","owner":[],"postedDate":"May 2nd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-02-24T16:00:27+00:00","versionOfRecord":{"articleIdentity":"rs-4266210","link":"https://doi.org/10.1007/s00520-025-09265-4","journal":{"identity":"supportive-care-in-cancer","isVorOnly":false,"title":"Supportive Care in Cancer"},"publishedOn":"2025-02-19 15:56:56","publishedOnDateReadable":"February 19th, 2025"},"versionCreatedAt":"2024-05-02 13:22:02","video":"","vorDoi":"10.1007/s00520-025-09265-4","vorDoiUrl":"https://doi.org/10.1007/s00520-025-09265-4","workflowStages":[]},"version":"v1","identity":"rs-4266210","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4266210","identity":"rs-4266210","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}