Clinical Outcomes of Plastic versus Self-Expanding Metal Stents in Malignant Hilar Biliary Obstruction

Clinical Outcomes of Plastic versus Self-Expanding Metal Stents in Malignant Hilar Biliary Obstruction | 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 Article Clinical Outcomes of Plastic versus Self-Expanding Metal Stents in Malignant Hilar Biliary Obstruction Pastor Joaquín Ortiz Mendieta, Bruno Martins, Deborah Marques Centeno, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6537218/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract This retrospective study compared plastic stents (PS) and self-expanding metal stents (SEMS) in 86 patients with unresectable malignant hilar biliary obstruction (MHBO) treated between 2015 and 2022. In univariate analysis, SEMS were associated with higher clinical success (76.9% vs. 51.1%) and significantly longer stent patency (median 213 vs. 78 days) compared to PS. They also showed a lower risk of recurrent biliary obstruction. However, overall survival did not differ significantly between groups. Multivariate analysis revealed that better ECOG performance status and lower bilirubin levels, rather than stent type, predicted improved clinical outcomes. SEMS offer superior durability, but stent selection should be guided by individual patient characteristics. Health sciences/Gastroenterology Health sciences/Oncology Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 INTRODUCTION Malignant hilar biliary obstruction (MBHO) has a dismal prognosis, with an estimated 5-year survival rate of less than 10%.( 1 , 2 ) It arises from various malignancies, including hilar cholangiocarcinoma, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, and metastases. ( 1 , 3 , 4 ). Patients typically present with cholestatic jaundice.( 1 , 5 ) Due to early nonspecific symptoms, most patients (around 73 % )( 1 ) are diagnosed at an advanced stage, limiting the potential for curative resection. ( 1 , 6 – 9 ) For patients with advanced MHBO who are not candidates for surgical resection or neoadjuvant chemotherapy, palliative chemotherapy is often indicated to extend survival. However, recurrent biliary obstruction (RBO) after stenting for malignancy can compromise treatment, and lead to life-threatening complications such as acute cholangitis. ( 7 , 10 ) Therefore, the effective management of jaundice and the prevention of cholangitis are essential for continued chemotherapy. ( 6 , 11 , 12 ) Endoscopic drainage using stent placement is the preferred palliative approach because it is less invasive than surgical or percutaneous alternatives. ( 5 , 13 ) However, there is no consensus on the ideal drainage strategy or the best type of stent. ( 1 , 3 , 14 ) Among the available stents, plastic stents (PS) and uncovered self-expanding metallic stents (SEMS) are commonly used. ( 15 , 16 ) The ideal stent should not only relieve jaundice effectively but also provide sustained patency. ( 7 , 10 , 14 ) While many studies have shown that SEMS result in lower dysfunction rates and longer patency compared to PS, their clinical benefits and impact on survival remain controversial. Some studies report improved clinical success and survival rates with SEMS. ( 3 , 8 ), but these findings have not been consistently replicated. ( 6 , 9 , 17 ) Although there is general agreement that SEMS offer longer patency and reduced dysfunction, one study highlighted a higher incidence of percutaneous transhepatic cholangiogram drainage (PTC) in patients with SEMS. ( 9 ) Advances in systemic treatments, such as chemotherapy, immunotherapy, and targeted therapies, have contributed to longer survival in patients ( 18 – 20 ), potentially increasing the need for additional interventions due to recurrent bile duct obstructions. Therefore, in the context of reintervention, it is crucial to consider the risk of drainage failure, which may demand PTC. OBJECTIVE: The primary aim of this study was to assess the clinical success rate and stent patency rates of endoscopic drainage using SEMS versus PS in patients with unresectable malignant hilar biliary obstruction. Secondary objectives included overall survival, reintervention rates and the need for PTC. METHODS Study design This retrospective study was conducted at the Instituto do Câncer do Estado de São Paulo. Data on endoscopic retrograde cholangiopancreatography (ERCP) procedures were retrieved from the ERCP database for malignant neoplasms. The study was approved by the Ethics Committee of our institution (Scientific Teaching and Research Committee – CCEP 4071/23) and was registered in the National Database for Human Research (Plataforma Brasil - CAAE 70246623.1.0000.0068). Patients: Patients with unresectable MBHO classified as Bismuth II to IV who underwent endoscopic drainage between January 2015 and December 2022 were included in the study. Informed consent was obtained from all patients prior to the procedure. They were followed from the date of the first procedure at our institution until the date of death or until December 2023. Patients with drainage failure or those who had simultaneous placement of plastic and metal stents were excluded. Whenever possible, neoplasm histology was obtained based on brush cytology or biopsies taken during ERCP, Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), percutaneous puncture or surgical biopsy. In patients without tissue evidence of malignancy, the diagnosis was based on imaging (Computed Tomography, Magnetic Resonance Imaging) combined with patient history and clinical outcomes during follow-up. Procedure ERCP was performed by advanced endoscopy fellows under the supervision of experienced endoscopists, who performed > 200 ERCP per year. All procedures were performed under general anesthesia. After successful biliary cannulation and positioning of the guidewire across the stricture, bile was aspirated to decompress the obstruct duct, followed by contrast injection. Biliary sphincterotomy was performed at the operator discretion. When possible, two or more guidewires were introduced to reach more than one intrahepatic duct or to perform selective drainage of different segments. The type, diameter and number of stents were defined according to the decision of the endoscopist, with preference for the most dilated segments and preserved liver parenchyma. Drainage of ≥ 50% of the liver has generally been attempted, or at least 33%, in patients with preserved liver function. If drainage of more than one sector was not possible, the drainage of only one was attempted, prioritizing the largest portion of liver volume. The target lobes to be drained were decided by the operators according to the cross-sectional image evaluated before the procedure. Drainage of atrophic segments or segments diffusely occupied by the tumor or metastasis was avoided. If necessary, before stent insertion, the hilum stenosis was dilated with a dilation bougie (Cook Medical, Bloomington, IN, USA) and/or a balloon (QBD 4mm or 6mm, Cook Medical, Bloomington, IN, USA). Reintervention was performed in symptomatic patients with RBO. In patients with good performance status and controlled disease at cross-sectional image, a scheduled stent replacement before RBO was also performed. During endoscopic re-interventions, the plastic stents were removed and new plastic stents or metallic stents were placed. In the case of metal stents dysfunction, plastic stents or a new uSEMS were placed inside the previous SEMS. Patients who failed endoscopic reintervention were sent to PTC. EUS-guided hepaticogastrostomy was not part of the management algorithm of these patients. Straight plastic stents of 7, 8.5 or 10 Fr were used (Advanix biliary stents - Boston Scientific Corporation, MA, USA). The length was chosen based on the location of the stenoses. The SEMS were uncovered, 8 mm to 10 mm diameter, 8 cm – 10 cm long, WallFlex Biliary RX Uncovered Stent (Boston Scientific Corporation, MA, USA), Biliary stent Non-Covered (Micro-Tech, Nanjing, China) and HANAROSTENT® Biliary (Olympus Corporation, Shinjuku, Tokyo, Japan). Definitions Technical success was defined as the successful implantation of single or multiple stents, through the biliary stenosis, with drainage of at least one hepatic sector. ( 19 ) Clinical success was considered when the serum bilirubin level decreased to normal (≤ 1.2 mg/dL) or there was a ≥ 50% reduction in the value prior to stent placement, within 14 days of drainage, without further intervention. ( 4 , 9 , 19 ) Recurrent biliary obstruction was defined as stent dysfunction due to occlusion or migration, causing an increase in serum bilirubin and/or clinical symptoms as cholangitis. ( 19 ) Stent patency was measured from initial placement to RBO or patient death. Reintervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage after RBO. Overall survival was defined as the time from the first endoscopic stent placement to the moment of death. Statistical analysis Quantitative variables were assessed using either unpaired Student’s t-tests (for parametric data) or Mann-Whitney U tests (for non-parametric data). Qualitative or categorical variables were described as simple frequencies and percentages, and group comparisons were made using the Chi-square test or Fisher’s Exact test when appropriate. Survival and stent patency were analyzed using Kaplan-Meier curves, with the log-rank test applied to independent variables such as sex, age, stenosis level, Eastern cooperative oncology group scale (ECOG), stent type, bilirubin level, cholangitis. Multivariate analysis for clinical success (dependent variable) was performed using binary logistic regression, considering independent variables such as gender, age, stenosis level, ECOG, stent type, bilirubin level, and cholangitis. Proportional hazards Cox regression was employed for survival and patency outcomes, with the same covariates. Statistical significance was defined as p ≤ 0.05. All analyses were conducted using SPSS version 22.0. RESULTS We retrospectively evaluated 93 patients, of whom 7 were excluded (4 due to drainage failure and 3 who were treated simultaneously with plastic and metal stents). Finally, 86 patients successfully treated by ERCP were included for analysis (31 men and 55 women). Of these, 34 (39.5%) had a diagnosis of hilar cholangiocarcinoma, 44 (51.16%) had metastatic tumors, and 8 (9.31%) had gallbladder cancer. A total of 39 patients received SEMS, while 47 received PS. The groups were similar at baseline, except for a higher number of patients with ECOG 0–2 in the SEMS group compared to the PS group (p = 0.043). Figure 1 presents the study flowchart, and the baseline characteristics of the patients are summarized in Table 1 . Table 1 Baseline patients characteristics Variable Category Stent Total p-value SEMS PS n % n % n Age < 60 22 52.4% 20 47.6% 42 0.279 ≥ 60 17 38.6% 27 61.4% 44 Gender F 23 41.8% 32 58.2% 55 0.499 M 16 51.6% 15 48.4% 31 Bismuth classification II 14 60.9% 9 39.1% 23 0.233 III 10 38.5% 16 61.5% 26 IV 15 40.5% 22 59.5% 37 Aetiology Cholangiocellular carcinoma 14 41.2% 20 58.8% 34 0.583 Gallbladder cancer 5 62.5% 3 37.5% 8 Metastatic tumor 20 45.5% 24 54.5% 44 ECOG 0–2 34 51.5% 32 48.5% 66 0.043 3–4 5 25% 15 75% 20 Bilirubin level < 10 22 53.7% 19 46.3% 41 0.193 ≥ 10 17 37.8% 28 62.2% 45 Cholangitis No 32 48.5% 34 51.5% 66 0.318 Yes 7 35% 13 65% 20 ECOG: Eastern cooperative oncology group scale; SEMS: self-expanding metallic stents; PS: plastic stents. Comparison of outcomes between the type of stents (SEMS vs PS) Clinical success was observed in 76.9% of patients in the SEMS group, compared with 51.1% in the PS group (p = 0.015). Reintervention to restore biliary drainage was required in 16 patients (41.02%) of the SEMS group and 24 patients (51.06%) of the PS group. The technique used for the first reintervention is summarized on Fig. 1 . The mean time to reintervention was significantly longer in the SEMS group (132.4 ± 129.38 days vs. 66.7 ± 85.71 days; p = 0.028), as was the mean survival (301.3 ± 400.7 days vs. 183.7 ± 365.5 days; p = 0.023). Also, there was a higher number of patients who could receive chemotherapy after drainage in the SEMS group (SEMS 61.5% vs PS 29.8%; p = 0.003). There was no statistically significant difference between the groups regarding the mean number of endoscopic reinterventions (SEMS 0.92 vs. PS 0.79; p = 1.00), total reinterventions (SEMS 1.15 vs. PS 1.00; p = 0.807), or the need for PTC (SEMS 23.1% vs. PS 21.3%; p = 1.00). These results are summarized in Table 2 . Table 2 Comparison of clinical outcomes between the SEMS group versus the plastic stent group SEMS (n = 39) PS (n = 47) p-value Clinical success n (%) 30 (76.9%) 24 (51.1%) 0.015 Endoscopic reinterventions (mean) 0.92 0.79 1.000 Total reinterventions (mean) 1.15 1.00 0.807 Time to reintervention (days) (mean) 132.4 (± 129.4) 66.7 (± 85.7) 0.028 Survival (days) (mean) 301.3 (± 400.7) 183.7 (± 365.5) 0.023 PTC n (%) 9 (23.1%) 19 (21.3%) 1.000 Chemotherapy post-drainage 24 (61.5%) 14 (29.8%) 0.003 PTC: percutaneous transhepatic cholangiogram drainage; SEMS: self-expanding metallic stents; PS: plastic stents. Clinical Success Patients with Bismuth II and III stenoses demonstrated significantly higher clinical success rates compared to those with Bismuth IV (p = 0.019). Similarly, patients with better performance status (ECOG 0–2) showed greater clinical success than those with ECOG 3–4 (71% vs. 35%, p = 0.004). Clinical success was also more frequent among patients who received SEMS (p = 0.015) and those with baseline bilirubin levels below 10 mg/dL (p = 0.007). No significant associations were found between clinical success and age, gender, or the presence of cholangitis. Table 3 Association between patients’ characteristics and clinical success Variable Category Clinical success Total p-value No Yes n % n % n Age < 60 14 33.3% 28 66.7% 42 0.509 ≥ 60 18 40.9% 26 59.1% 44 Gender F 21 38.2% 34 61.8% 55 0.821 M 11 35.5% 20 64.5% 31 Bismuth cassification II 6 26.1% 17 73.9% 23 0.019 III 6 23.1% 20 76.9% 26 IV 20 54.1% 17 45.9% 37 ECOG 0–2 19 28.8% 47 71.2% 66 0.004 3–4 13 65% 7 35% 20 Stent SEMS 9 23.1% 30 76.9% 39 0.015 PS 23 48.9% 24 51.1% 47 Bilirubin level < 10 9 22% 32 78% 41 0.007 ≥ 10 23 51.1% 22 48.9% 45 Cholangitis No 26 39.4% 40 60.6% 66 0.599 Yes 6 30% 14 70% 20 ECOG: Eastern cooperative oncology group scale. Univariate analysis corroborated the findings of the Chi-square analysis, reinforcing the associations between clinical success and Bismuth classification, ECOG performance status, stent type, and baseline bilirubin levels. Additionally, for each one-point increase in pre-drainage bilirubin level, the likelihood of clinical success decreased by 8% (OR 0.92, 95% CI 0.86–0.99; p = 0.021). In the multivariate analysis, however, SEMS was not associated with clinical success (OR 0.43, 95% CI 0.14–1.29; p = 0.131). Conversely, Bismuth II obstruction level (OR 4.58, 95% CI 1.28–16.36; p = 0.019), Bismuth III obstruction level (OR 5.36, 95% CI 1.48–19.36; p = 0.010), ECOG 0–2 (OR 0.18, 95% CI 0.06–0.61; p = 0.006), and lower pre-drainage bilirubin levels (OR 0.92, 95% CI 0.86-1.00; p = 0.038) were independently associated with higher clinical success rates. Table 4 presents the results of binary logistic regressions for clinical success. Table 4 . Uni and multivariate logistic regression for predictive factors of clinical success Variable Category Univariate Multivariate OR (CI 95%) p-value OR (CI 95%) p-value Age <60 1.00 ≥60 0.72 (0.30-1.74) 0.468 Gender F 0.89 (0.36-2.22) 0.804 M 1.00 Bismuth classification II 3.33 (1.07-10.35) 0.037 4.58 (1.28-16.36) 0.019 III 3.92 (1.28-12.0) 0.017 5.36 (1.48-19.36) 0.010 IV 1.00 1.00 ECOG 0-2 1.00 1.00 3-4 0.22 (0.8-0.63) 0.005 0.18 (0.06-0.61) 0.006 Stent SEMS 1.00 1.00 PS 0.31 (0.12-0.80) 0.015 0.43 (0.14-1.29) 0.131 Cholangitis No 0.66 (0.22-1.93) 0.448 Yes 1.00 Bilirubin level 0.92 (0.86-0.99) 0.021 0.92 (0.86-1.00) 0.038 ECOG: Eastern cooperative oncology group scale; OR: odds ratio; CI: confidence interval. Patency – time to recurrent biliary obstruction Kaplan-Meier curves and the log-rank test were applied to the categorical variables: age, gender, Bismuth level, ECOG score, and type of stent (plastic versus metallic). SEMS demonstrated significantly higher patency rates, as determined by the log-rank test (p = 0.01) (Figure 2). No significant differences were found between the groups for the other tested variables. The univariate Cox regression analysis showed that the PS group had a RR of 2.22 (95% CI 1.19-4.12; p = 0.012), indicating higher chances of recurrent biliary obstruction compared to the SEMS group. This finding was confirmed by multivariate analysis, with an RR of 3.17 (95% CI 1.60-6.27; p = 0.001) (Table 5). Table 5 : Cox proportional regression analysis for stent patency Variable Category Univariate Multivariate RR (CI 95%) p-value RR (CI 95%) p-value Age <60 1.00 1.00 ≥60 0.76 (0.42-1.40) 0.384 0.55 (0.29-1.04) 0.065 Gender F 1.21 (0.64-2.30) 0.555 M 1.00 Bismuth classification II 0.97 (0.46-2.05) 0.941 III 1.21 (0.60-2.46) 0.596 IV 1.00 ECOG 0-2 1.00 1.00 3-4 0.62 (0.26-1.48) 0.284 0.43 (0.18-1.06) 0.067 Stent SEMS 1.00 1.00 PS 2.22 (1.19-4.12) 0.012 3.17 (1.60-6.27) 0.001 Cholangitis No 0.81 (0.42-1.58) 0.541 Yes 1.00 Bilirubin level 1.03 (0.98-1.08) 0.234 1.04 (0.99-1.09) 0.116 ECOG: Eastern cooperative oncology group scale; RR: relative risk; CI: confidence interval. Survival The log-rank test showed higher survival rates (p = 0.022) for patients with better performance status (ECOG 0-2), and for those with bilirubin levels < 10 mg/dL (p = 0.003). Patients with SEMS showed a marginal, non-statistically significant difference in survival compared to those with plastic stents (p = 0.059) (Figures 3,4 and 5). At univariate Cox regression analysis, patients with ECOG 3-4 had a 1.81 times higher risk of death compared to those with ECOG 0-2 (95% CI 1.08-3.05; p=0.025). Additionally, for each unit increase in bilirubin, the risk of death increased by 6% (95% CI 1.02-1.09; p=0.002). Patients with PS had a 1.53 times higher risk of death compared to those with SEMS, although this difference was marginal and not statistically significant (95% CI 0.98-2.40; p = 0.062). In multivariate analysis, ECOG and bilirubin levels were confirmed as significant risk factors (Table 6). Table 6 : Proportional Cox regressions for survival. Variable Category Univariate Multivariate RR (CI 95%) p-value RR (CI 95%) p-value Age <60 1.00 ≥60 1.08 (0.69.1.68) 0.743 Gender F 1.04 (0.66-1.65) 0.865 M 1.00 Bismuth classification II 1.16 (0.66-2.02) 0.604 III 1.17 (0.69-1.99) 0.557 IV 1.00 ECOG 0-2 1.00 1.00 3-4 1.81 (1.08-3.05) 0.025 1.77 (1.05-2.98) 0.033 Stent SEMS 1.00 PS 1.53 (0.98-2.40) 0.062 Cholangitis No 1.23 (0.72-2.08) 0.453 Yes 1.00 Bilirubin level 1.06 (1.02-1.09) 0.002 1.05 (1.02-1.09) 0.003 ECOG: Eastern cooperative oncology group scale; RR: relative risk; CI: confidence interval. DISCUSSION This study evaluated the clinical success, stent patency, and survival outcomes of self-expanding metal stents compared to plastic stents in the palliative treatment of malignant hilar biliary obstruction. We found that SEMS demonstrated superior patency, with a significantly lower risk of recurrent biliary obstruction compared to PS. However, clinical success and survival outcomes did not differ significantly between the groups. These results align with previous studies supporting the prolonged patency of SEMS while challenging the notion of a definitive survival advantage. Two previous studies reported higher clinical success rates with SEMS (Xia: 99% vs. 71%; Sangchan: 70.4% vs. 46.3%) ( 3 , 8 ), while two others found no significant difference. ( 6 , 9 ) In our study, although SEMS was associated with higher clinical success in the univariate analysis (76.9% vs. 51.1%; p = 0.015), this finding was not confirmed in multivariate analysis, suggesting that the apparent benefit of SEMS may be influenced by other factors, such as ECOG status. Therefore, SEMS alone does not independently predict better clinical outcomes in our cohort. However, although patients with SEMS did not experience improved clinical outcomes, they derived greater benefit from post-drainage chemotherapy. The greater concentration of ECOG 3–4 patients in the PS group could also explain the more frequent use of chemotherapy in the SEMS group. We also analyzed additional variables that could correlate with clinical success. In both univariate and multivariate analyses, higher success rates were observed in patients with Bismuth II and III obstructions compared to Bismuth IV, reinforcing the challenge of effectively draining more complex hilar strictures. Better ECOG performance status (0–2) was also significantly associated with clinical success, as were lower baseline bilirubin levels (< 10 mg/dL). Notably, for each one-unit increase in bilirubin, the likelihood of clinical success decreased by 8%. These findings highlight the role of patient-related factors in determining treatment success, rather than stent type alone. SEMS demonstrated superior patency compared to PS in Kaplan-Meier analysis (median 213 days vs. 78 days), a result confirmed in both univariate and multivariate analyses. This aligns with previous reports ( 3 , 6 , 9 , 17 ), reinforcing that SEMS reduce the likelihood of early recurrent biliary obstruction. Given the higher dysfunction rates of PS, it was expected that these patients would require more reinterventions to maintain biliary drainage. Indeed, five prior studies have reported a higher number of reinterventions in patients receiving PS ( 3 , 6 , 9 , 17 , 21 ), while one found no significant difference. ( 8 ) However, in our study, no difference was observed in the total number of reinterventions or endoscopic reinterventions. This may be explained by the longer median survival in SEMS patients, increasing the likelihood of prosthesis revision due to occlusion or failure over time. A prior study ( 9 ) reported a higher need for percutaneous transhepatic drainage (PTC) in patients with SEMS (50% vs. 22.2% for PS); however, this was not replicated in our cohort, where no significant difference was observed. This suggests that the need for additional drainage procedures may be more dependent on patient-specific factors and disease progression rather than stent selection. Regarding survival, a literature review identified two studies reporting longer survival with SEMS ( 3 , 8 ), whereas three others found no significant difference. ( 6 , 9 , 17 ) In our study, univariate analysis initially showed a survival benefit for SEMS (median 301 vs. 183 days; p = 0.023); however, this difference was not confirmed in multivariate analysis, where only a trend favoring SEMS was observed (p = 0.059). This suggests that the initial survival advantage seen with SEMS may have been influenced by the more favorable ECOG status of this group. Complementary analyses showed that survival was significantly associated with ECOG 0–2 and bilirubin levels below 10 mg/dL, with each one-point increase in bilirubin correlating with a 6% higher risk of death. This study has some limitations. It was a retrospective analysis conducted at a referral center, which may limit the generalizability of our findings to other institutions. Additionally, stent selection (SEMS vs. PS) was determined at the discretion of the endoscopist, potentially introducing selection bias. The baseline ECOG status differed between the groups, which may have influenced some of the observed differences. However, aside from ECOG, other baseline characteristics were comparable between groups. Effective biliary drainage in MHBO requires careful planning, often involving a multidisciplinary evaluation including interventional radiology, surgery, clinical oncology, and endoscopy. This procedure should ideally be performed in specialized centers with experienced personnel. Several factors should be considered when selecting the optimal stent, including tumor extent, anatomical involvement, expected survival, and quality of life. Conclusion In patients with malignant hilar obstruction, SEMS demonstrated superior patency compared to PS but did not significantly impact overall survival. While univariate analysis suggested higher clinical success with SEMS, multivariate analysis showed only a marginal improvement. Clinical success was more strongly associated with better ECOG performance status and pre-drainage bilirubin levels below 10 mg/dL, while Bismuth type IV classification predicted lower success rates. Overall survival, the mean number of reinterventions, and the need for percutaneous transhepatic drainage were comparable between the two groups. These findings highlight the importance of patient selection criteria beyond stent type when determining optimal biliary drainage strategies in MHBO. Declarations Author Contribution PJOM and BM: wrote the main manuscript textDMC, JMG and RUS: Prepared figures and tablesAVSF, CMPSP, CCG, GAP, LHLT, MSL, RNM, SNG: Data collectionFMF: review and final approvalAll authors reviewed the manuscript References Qumseya BJ, Jamil LH, Elmunzer BJ, Riaz A, Ceppa EP, Thosani NC, et al. ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction. Gastrointest Endosc. 2021;94(2):222–234.e22. Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz J, et al. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg [Internet]. 2001 Oct 1 [cited 2025 Apr 25];234(4):507–19. Available from: https://pubmed.ncbi.nlm.nih.gov/11573044/ Xia MX, Pan YL, Cai XB, Wu J, Gao DJ, Ye X, et al. Comparison of endoscopic bilateral metal stent drainage with plastic stents in the palliation of unresectable hilar biliary malignant strictures: Large multicenter study. Digestive Endoscopy. 2021;33(1):179–89. Takahashi E, Fukasawa M, Sato T, Takano S, Kadokura M, Shindo H, et al. Biliary drainage strategy of unresectable malignant hilar strictures by computed tomography volumetry. World J Gastroenterol. 2015;21(16):4946–53. Vienne A, Hobeika E, Gouya H, Lapidus N, Fritsch J, Choury AD, et al. Prediction of drainage effectiveness during endoscopic stenting of malignant hilar strictures: The role of liver volume assessment. Gastrointest Endosc. 2010;72(4):728–35. Iwasaki A, Kubota K, Kurita Y, Hasegawa S, Fujita Y, Kagawa K, et al. The placement of multiple plastic stents still has important roles in candidates for chemotherapy for unresectable perihilar cholangiocarcinoma. J Hepatobiliary Pancreat Sci. 2020;27(10):700–11. Chiba M, Kato M, Kinoshita Y, Shimamoto N, Tomita Y, Abe T, et al. Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis. Sci Rep. 2020;10(1). Sangchan A, Kongkasame W, Pugkhem A, Jenwitheesuk K, Mairiang P. Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: A randomized controlled trial. Gastrointest Endosc. 2012;76(1):93–9. Choi JH, Lee SH, You MS, Shin B sup, Choi YH, Kang J, et al. Step-wise endoscopic approach to palliative bilateral biliary drainage for unresectable advanced malignant hilar obstruction. Sci Rep. 2019;9(1). Kiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2018;25(1):17–30. Martins BC, Perez CA, Ruas JN, Bento LH, Mendonça EQ, de Paulo GA, et al. Results of endoscopic biliary drainage in patients with malignant hilar stricture. Clinics. 2023;78. Sawas T, Al Halabi S, Parsi MA, Vargo JJ. Self-expandable metal stents versus plastic stents for malignant biliary obstruction: A meta-analysis. Vol. 82, Gastrointestinal Endoscopy. Mosby Inc.; 2015. p. 256–267.e7. Moole H, Dharmapuri S, Duvvuri A, Dharmapuri S, Boddireddy R, Moole V, et al. Endoscopic versus Percutaneous Biliary Drainage in Palliation of Advanced Malignant Hilar Obstruction: A Meta-Analysis and Systematic Review. Can J Gastroenterol Hepatol [Internet]. 2016 [cited 2025 Apr 25];2016. Available from: https://pubmed.ncbi.nlm.nih.gov/27648439/ Fukasawa M, Takano S, Shindo H, Takahashi E, Sato T, Enomoto N. Endoscopic biliary stenting for unresectable malignant hilar obstruction. Vol. 10, Clinical Journal of Gastroenterology. Springer Tokyo; 2017. p. 485–90. Tringali A, Boškoski I, Costamagna G. Endoscopic Stenting in Hilar Cholangiocarcinoma: When, How, and How Much to Drain? 2019. Zorrón Pu L, De Moura EGH, Bernardo WM, Baracat FI, Mendonça EQ, Kondo A, et al. Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol [Internet]. 2015 Dec 21 [cited 2025 Apr 25];21(47):13374–85. Available from: https://pubmed.ncbi.nlm.nih.gov/26715823/ Mukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, et al. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: A randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013;20(2):214–22. Angsuwatcharakon P, Kulpatcharapong S, Chuncharunee A, Khor C, Devereaux B, Moon JH, et al. The updated Asia-Pacific consensus statement on the role of endoscopic management in malignant hilar biliary obstruction. Endosc Int Open. 2024; Isayama H, Hamada T, Fujisawa T, Fukasawa M, Hara K, Irisawa A, et al. TOKYO criteria 2024 for the assessment of clinical outcomes of endoscopic biliary drainage. Digestive Endoscopy. John Wiley and Sons Inc; 2024. Kadayifci A, Atar M, Forcione DG, Casey BW, Kelsey PB, Brugge WR. Radiofrequency ablation for the management of occluded biliary metal stents. Endoscopy [Internet]. 2016 Dec 1 [cited 2025 Apr 25];48(12):1096–101. Available from: https://pubmed.ncbi.nlm.nih.gov/27716861/ Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy [Internet]. 1993 [cited 2025 Apr 22];25(3):213–8. Available from: https://pubmed.ncbi.nlm.nih.gov/7686100/ Additional Declarations No competing interests reported. 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Mendieta","email":"data:image/png;base64,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","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":true,"prefix":"","firstName":"Pastor","middleName":"Joaquín Ortiz","lastName":"Mendieta","suffix":""},{"id":454046448,"identity":"a511bcdd-b564-42cf-9bbb-07c5e4566125","order_by":1,"name":"Bruno Martins","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Bruno","middleName":"","lastName":"Martins","suffix":""},{"id":454046449,"identity":"ae488bc9-7865-4ea7-98ae-75cbab5effc7","order_by":2,"name":"Deborah Marques Centeno","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Deborah","middleName":"Marques","lastName":"Centeno","suffix":""},{"id":454046450,"identity":"bb9be264-71ad-4541-908f-d26f4a6849ba","order_by":3,"name":"Julia Mayumi Gregorio","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Julia","middleName":"Mayumi","lastName":"Gregorio","suffix":""},{"id":454046451,"identity":"dc4a40e4-a9a1-40e6-b5a1-aff434d393f7","order_by":4,"name":"Rafael Utimura Sueta","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Rafael","middleName":"Utimura","lastName":"Sueta","suffix":""},{"id":454046452,"identity":"b3931748-fba5-4fe1-a935-0d97714d30de","order_by":5,"name":"Adraina Vaz Safatle Ribeiro","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Adraina","middleName":"Vaz Safatle","lastName":"Ribeiro","suffix":""},{"id":454046453,"identity":"47068577-5122-4504-9dc6-2f6aa1993941","order_by":6,"name":"Caterina Maria Pia Simoni Pennacchi","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Caterina","middleName":"Maria Pia Simoni","lastName":"Pennacchi","suffix":""},{"id":454046454,"identity":"7467c43e-c27a-417f-8213-a1fea4da90d7","order_by":7,"name":"Carla Cristina Gusmon","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Carla","middleName":"Cristina","lastName":"Gusmon","suffix":""},{"id":454046455,"identity":"fae7abda-945f-4ab2-af7f-5753d62d5ab0","order_by":8,"name":"Gustavo Andrade de Paulo","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Gustavo","middleName":"Andrade","lastName":"de Paulo","suffix":""},{"id":454046456,"identity":"86866452-9ff4-4e18-a9af-05c9b2eed350","order_by":9,"name":"Luciano Henrique Lenz Tolentino","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Luciano","middleName":"Henrique Lenz","lastName":"Tolentino","suffix":""},{"id":454046457,"identity":"51465c9e-e62a-469a-afb4-7765f71b9c94","order_by":10,"name":"Marcelo Simas de Lima","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Marcelo","middleName":"Simas","lastName":"de Lima","suffix":""},{"id":454046458,"identity":"6cb8970a-c3c6-4726-a2e4-d088f03739c3","order_by":11,"name":"Renata Nobre Moura","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Renata","middleName":"Nobre","lastName":"Moura","suffix":""},{"id":454046459,"identity":"f247789c-4cd8-4f4a-a3a7-20c2ba02502e","order_by":12,"name":"Sebastian Naschold Geiger","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Sebastian","middleName":"Naschold","lastName":"Geiger","suffix":""},{"id":454046460,"identity":"70961256-9a73-4632-9c73-6c1f261b04e5","order_by":13,"name":"Fauze Maluf-Filho","email":"","orcid":"","institution":"Instituto do Câncer do Estado de São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Fauze","middleName":"","lastName":"Maluf-Filho","suffix":""}],"badges":[],"createdAt":"2025-04-27 00:53:06","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6537218/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6537218/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":82620384,"identity":"689dfcf9-77d7-46e9-9fbe-8fb0db9460f9","added_by":"auto","created_at":"2025-05-13 12:13:35","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":142432,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart patients\u003c/p\u003e","description":"","filename":"image1.png","url":"https://assets-eu.researchsquare.com/files/rs-6537218/v1/514aff00fc2e06d9e970162c.png"},{"id":82620380,"identity":"193f55f3-2e19-4068-8328-2771e8277624","added_by":"auto","created_at":"2025-05-13 12:13:35","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":71114,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meir analysis of the patency rates in the SEMS group versus Plastic Stent group.\u003c/p\u003e","description":"","filename":"image2.png","url":"https://assets-eu.researchsquare.com/files/rs-6537218/v1/8cfd69a2301b909ee965818f.png"},{"id":82620378,"identity":"0aa6879f-d906-48fd-ba08-db21032ca592","added_by":"auto","created_at":"2025-05-13 12:13:35","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":62455,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meier curve of overall survival according ECOG.\u003c/p\u003e","description":"","filename":"image3.png","url":"https://assets-eu.researchsquare.com/files/rs-6537218/v1/e46912922bb18e169ed20f59.png"},{"id":82620382,"identity":"d11ad985-1e83-455d-a692-fcdc8f4d10b1","added_by":"auto","created_at":"2025-05-13 12:13:35","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":72615,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meier curve of overall survival according type of stent.\u003c/p\u003e","description":"","filename":"image4.png","url":"https://assets-eu.researchsquare.com/files/rs-6537218/v1/a91b4357b5cb1cb5c062fc3b.png"},{"id":82620392,"identity":"1c343ad0-8791-44ba-8d89-96a2e0facf63","added_by":"auto","created_at":"2025-05-13 12:13:36","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":70886,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meier curve of overall survival according to bilirubin level.\u003c/p\u003e","description":"","filename":"image5.png","url":"https://assets-eu.researchsquare.com/files/rs-6537218/v1/284a938f5cc689f441d72c93.png"},{"id":83817789,"identity":"c4e8cfea-3a18-441e-ba0e-3f8b59ab6ede","added_by":"auto","created_at":"2025-06-03 08:02:07","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1259801,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6537218/v1/12132ee6-4822-4339-9f50-a6b86171a11e.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Clinical Outcomes of Plastic versus Self-Expanding Metal Stents in Malignant Hilar Biliary Obstruction","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eMalignant hilar biliary obstruction (MBHO) has a dismal prognosis, with an estimated 5-year survival rate of less than 10%.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) It arises from various malignancies, including hilar cholangiocarcinoma, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, and metastases. (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Patients typically present with cholestatic jaundice.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) Due to early nonspecific symptoms, most patients (around 73\u003cb\u003e%\u003c/b\u003e)(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) are diagnosed at an advanced stage, limiting the potential for curative resection. (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan additionalcitationids=\"CR7 CR8\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eFor patients with advanced MHBO who are not candidates for surgical resection or neoadjuvant chemotherapy, palliative chemotherapy is often indicated to extend survival. However, recurrent biliary obstruction (RBO) after stenting for malignancy can compromise treatment, and lead to life-threatening complications such as acute cholangitis. (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) Therefore, the effective management of jaundice and the prevention of cholangitis are essential for continued chemotherapy. (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eEndoscopic drainage using stent placement is the preferred palliative approach because it is less invasive than surgical or percutaneous alternatives. (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) However, there is no consensus on the ideal drainage strategy or the best type of stent. (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) Among the available stents, plastic stents (PS) and uncovered self-expanding metallic stents (SEMS) are commonly used. (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) The ideal stent should not only relieve jaundice effectively but also provide sustained patency. (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eWhile many studies have shown that SEMS result in lower dysfunction rates and longer patency compared to PS, their clinical benefits and impact on survival remain controversial. Some studies report improved clinical success and survival rates with SEMS. (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), but these findings have not been consistently replicated. (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) Although there is general agreement that SEMS offer longer patency and reduced dysfunction, one study highlighted a higher incidence of percutaneous transhepatic cholangiogram drainage (PTC) in patients with SEMS. (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eAdvances in systemic treatments, such as chemotherapy, immunotherapy, and targeted therapies, have contributed to longer survival in patients (\u003cspan additionalcitationids=\"CR19\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e), potentially increasing the need for additional interventions due to recurrent bile duct obstructions. Therefore, in the context of reintervention, it is crucial to consider the risk of drainage failure, which may demand PTC.\u003c/p\u003e\n\u003ch3\u003eOBJECTIVE:\u003c/h3\u003e\n\u003cp\u003eThe primary aim of this study was to assess the clinical success rate and stent patency rates of endoscopic drainage using SEMS versus PS in patients with unresectable malignant hilar biliary obstruction. Secondary objectives included overall survival, reintervention rates and the need for PTC.\u003c/p\u003e "},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003cdiv id=\"Sec4\" class=\"Section3\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThis retrospective study was conducted at the Instituto do C\u0026acirc;ncer do Estado de S\u0026atilde;o Paulo. Data on endoscopic retrograde cholangiopancreatography (ERCP) procedures were retrieved from the ERCP database for malignant neoplasms. The study was approved by the Ethics Committee of our institution (Scientific Teaching and Research Committee \u0026ndash; CCEP 4071/23) and was registered in the National Database for Human Research (Plataforma Brasil - CAAE 70246623.1.0000.0068).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e\n\u003ch3\u003ePatients:\u003c/h3\u003e\n\u003cp\u003ePatients with unresectable MBHO classified as Bismuth II to IV who underwent endoscopic drainage between January 2015 and December 2022 were included in the study. Informed consent was obtained from all patients prior to the procedure. They were followed from the date of the first procedure at our institution until the date of death or until December 2023. Patients with drainage failure or those who had simultaneous placement of plastic and metal stents were excluded.\u003c/p\u003e \u003cp\u003eWhenever possible, neoplasm histology was obtained based on brush cytology or biopsies taken during ERCP, Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), percutaneous puncture or surgical biopsy. In patients without tissue evidence of malignancy, the diagnosis was based on imaging (Computed Tomography, Magnetic Resonance Imaging) combined with patient history and clinical outcomes during follow-up.\u003c/p\u003e\n\u003ch3\u003eProcedure\u003c/h3\u003e\n\u003cp\u003eERCP was performed by advanced endoscopy fellows under the supervision of experienced endoscopists, who performed\u0026thinsp;\u0026gt;\u0026thinsp;200 ERCP per year. All procedures were performed under general anesthesia.\u003c/p\u003e \u003cp\u003eAfter successful biliary cannulation and positioning of the guidewire across the stricture, bile was aspirated to decompress the obstruct duct, followed by contrast injection. Biliary sphincterotomy was performed at the operator discretion. When possible, two or more guidewires were introduced to reach more than one intrahepatic duct or to perform selective drainage of different segments.\u003c/p\u003e \u003cp\u003eThe type, diameter and number of stents were defined according to the decision of the endoscopist, with preference for the most dilated segments and preserved liver parenchyma. Drainage of \u0026ge;\u0026thinsp;50% of the liver has generally been attempted, or at least 33%, in patients with preserved liver function. If drainage of more than one sector was not possible, the drainage of only one was attempted, prioritizing the largest portion of liver volume. The target lobes to be drained were decided by the operators according to the cross-sectional image evaluated before the procedure. Drainage of atrophic segments or segments diffusely occupied by the tumor or metastasis was avoided. If necessary, before stent insertion, the hilum stenosis was dilated with a dilation bougie (Cook Medical, Bloomington, IN, USA) and/or a balloon (QBD 4mm or 6mm, Cook Medical, Bloomington, IN, USA).\u003c/p\u003e \u003cp\u003eReintervention was performed in symptomatic patients with RBO. In patients with good performance status and controlled disease at cross-sectional image, a scheduled stent replacement before RBO was also performed. During endoscopic re-interventions, the plastic stents were removed and new plastic stents or metallic stents were placed. In the case of metal stents dysfunction, plastic stents or a new uSEMS were placed inside the previous SEMS. Patients who failed endoscopic reintervention were sent to PTC. EUS-guided hepaticogastrostomy was not part of the management algorithm of these patients.\u003c/p\u003e \u003cp\u003eStraight plastic stents of 7, 8.5 or 10 Fr were used (Advanix biliary stents - Boston Scientific Corporation, MA, USA). The length was chosen based on the location of the stenoses. The SEMS were uncovered, 8 mm to 10 mm diameter, 8 cm \u0026ndash; 10 cm long, WallFlex Biliary RX Uncovered Stent (Boston Scientific Corporation, MA, USA), Biliary stent Non-Covered (Micro-Tech, Nanjing, China) and HANAROSTENT\u0026reg; Biliary (Olympus Corporation, Shinjuku, Tokyo, Japan).\u003c/p\u003e\n\u003ch3\u003eDefinitions\u003c/h3\u003e\n\u003cp\u003eTechnical success was defined as the successful implantation of single or multiple stents, through the biliary stenosis, with drainage of at least one hepatic sector. (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) Clinical success was considered when the serum bilirubin level decreased to normal (\u0026le;\u0026thinsp;1.2 mg/dL) or there was a\u0026thinsp;\u0026ge;\u0026thinsp;50% reduction in the value prior to stent placement, within 14 days of drainage, without further intervention. (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) Recurrent biliary obstruction was defined as stent dysfunction due to occlusion or migration, causing an increase in serum bilirubin and/or clinical symptoms as cholangitis. (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) Stent patency was measured from initial placement to RBO or patient death. Reintervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage after RBO. Overall survival was defined as the time from the first endoscopic stent placement to the moment of death.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eQuantitative variables were assessed using either unpaired Student\u0026rsquo;s t-tests (for parametric data) or Mann-Whitney U tests (for non-parametric data). Qualitative or categorical variables were described as simple frequencies and percentages, and group comparisons were made using the Chi-square test or Fisher\u0026rsquo;s Exact test when appropriate. Survival and stent patency were analyzed using Kaplan-Meier curves, with the log-rank test applied to independent variables such as sex, age, stenosis level, Eastern cooperative oncology group scale (ECOG), stent type, bilirubin level, cholangitis. Multivariate analysis for clinical success (dependent variable) was performed using binary logistic regression, considering independent variables such as gender, age, stenosis level, ECOG, stent type, bilirubin level, and cholangitis. Proportional hazards Cox regression was employed for survival and patency outcomes, with the same covariates. Statistical significance was defined as p\u0026thinsp;\u0026le;\u0026thinsp;0.05. All analyses were conducted using SPSS version 22.0.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eWe retrospectively evaluated 93 patients, of whom 7 were excluded (4 due to drainage failure and 3 who were treated simultaneously with plastic and metal stents). Finally, 86 patients successfully treated by ERCP were included for analysis (31 men and 55 women). Of these, 34 (39.5%) had a diagnosis of hilar cholangiocarcinoma, 44 (51.16%) had metastatic tumors, and 8 (9.31%) had gallbladder cancer. A total of 39 patients received SEMS, while 47 received PS. The groups were similar at baseline, except for a higher number of patients with ECOG 0\u0026ndash;2 in the SEMS group compared to the PS group (p\u0026thinsp;=\u0026thinsp;0.043). Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents the study flowchart, and the baseline characteristics of the patients are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline patients characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eCategory\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e \u003cp\u003eStent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eSEMS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003ePS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52.4%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e47.6%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.279\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38.6%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e61.4%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eF\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e41.8%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e58.2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e55\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.499\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e51.6%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e48.4%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eBismuth classification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e60.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e39.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e0.233\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e61.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e40.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e59.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eAetiology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCholangiocellular carcinoma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e41.2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e58.8%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e0.583\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGallbladder cancer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e62.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e37.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMetastatic tumor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e45.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e54.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eECOG\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u0026ndash;2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e51.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e48.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.043\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u0026ndash;4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e75%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eBilirubin level\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e53.7%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e46.3%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.193\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e37.8%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e62.2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eCholangitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e48.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e51.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.318\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e65%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eECOG: Eastern cooperative oncology group scale; SEMS: self-expanding metallic stents; PS: plastic stents.\u003c/p\u003e\n\u003ch3\u003eComparison of outcomes between the type of stents (SEMS vs PS)\u003c/h3\u003e\n\u003cp\u003eClinical success was observed in 76.9% of patients in the SEMS group, compared with 51.1% in the PS group (p\u0026thinsp;=\u0026thinsp;0.015). Reintervention to restore biliary drainage was required in 16 patients (41.02%) of the SEMS group and 24 patients (51.06%) of the PS group. The technique used for the first reintervention is summarized on Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The mean time to reintervention was significantly longer in the SEMS group (132.4\u0026thinsp;\u0026plusmn;\u0026thinsp;129.38 days vs. 66.7\u0026thinsp;\u0026plusmn;\u0026thinsp;85.71 days; p\u0026thinsp;=\u0026thinsp;0.028), as was the mean survival (301.3\u0026thinsp;\u0026plusmn;\u0026thinsp;400.7 days vs. 183.7\u0026thinsp;\u0026plusmn;\u0026thinsp;365.5 days; p\u0026thinsp;=\u0026thinsp;0.023). Also, there was a higher number of patients who could receive chemotherapy after drainage in the SEMS group (SEMS 61.5% vs PS 29.8%; p\u0026thinsp;=\u0026thinsp;0.003). There was no statistically significant difference between the groups regarding the mean number of endoscopic reinterventions (SEMS 0.92 vs. PS 0.79; p\u0026thinsp;=\u0026thinsp;1.00), total reinterventions (SEMS 1.15 vs. PS 1.00; p\u0026thinsp;=\u0026thinsp;0.807), or the need for PTC (SEMS 23.1% vs. PS 21.3%; p\u0026thinsp;=\u0026thinsp;1.00). These results are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of clinical outcomes between the SEMS group versus the plastic stent group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSEMS (n\u0026thinsp;=\u0026thinsp;39)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePS (n\u0026thinsp;=\u0026thinsp;47)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eClinical success n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e30 (76.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e24 (51.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.015\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEndoscopic reinterventions (mean)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal reinterventions (mean)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.807\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTime to reintervention (days) (mean)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e132.4 (\u0026plusmn;\u0026thinsp;129.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e66.7 (\u0026plusmn;\u0026thinsp;85.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.028\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurvival (days) (mean)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e301.3 (\u0026plusmn;\u0026thinsp;400.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e183.7 (\u0026plusmn;\u0026thinsp;365.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.023\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePTC n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e9 (23.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e19 (21.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChemotherapy post-drainage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e24 (61.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e14 (29.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.003\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003ePTC: percutaneous transhepatic cholangiogram drainage; SEMS: self-expanding metallic stents; PS: plastic stents.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eClinical Success\u003c/h2\u003e \u003cp\u003ePatients with Bismuth II and III stenoses demonstrated significantly higher clinical success rates compared to those with Bismuth IV (p\u0026thinsp;=\u0026thinsp;0.019). Similarly, patients with better performance status (ECOG 0\u0026ndash;2) showed greater clinical success than those with ECOG 3\u0026ndash;4 (71% vs. 35%, p\u0026thinsp;=\u0026thinsp;0.004). Clinical success was also more frequent among patients who received SEMS (p\u0026thinsp;=\u0026thinsp;0.015) and those with baseline bilirubin levels below 10 mg/dL (p\u0026thinsp;=\u0026thinsp;0.007). No significant associations were found between clinical success and age, gender, or the presence of cholangitis.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAssociation between patients\u0026rsquo; characteristics and clinical success\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eCategory\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e \u003cp\u003eClinical success\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e33.3%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e66.7%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.509\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e40.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e59.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eF\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38.2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e61.8%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e55\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.821\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e64.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e31\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eBismuth cassification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e73.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e0.019\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e23.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e76.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e54.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e45.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eECOG\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u0026ndash;2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e28.8%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e71.2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.004\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u0026ndash;4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e65%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e35%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eStent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSEMS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e23.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e76.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.015\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e48.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e51.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e47\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eBilirubin level\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e22%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e78%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.007\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e51.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e48.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eCholangitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e39.4%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e60.6%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.599\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e30%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e70%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eECOG: Eastern cooperative oncology group scale.\u003c/p\u003e \u003cp\u003eUnivariate analysis corroborated the findings of the Chi-square analysis, reinforcing the associations between clinical success and Bismuth classification, ECOG performance status, stent type, and baseline bilirubin levels. Additionally, for each one-point increase in pre-drainage bilirubin level, the likelihood of clinical success decreased by 8% (OR 0.92, 95% CI 0.86\u0026ndash;0.99; p\u0026thinsp;=\u0026thinsp;0.021).\u003c/p\u003e \u003cp\u003eIn the multivariate analysis, however, SEMS was not associated with clinical success (OR 0.43, 95% CI 0.14\u0026ndash;1.29; p\u0026thinsp;=\u0026thinsp;0.131). Conversely, Bismuth II obstruction level (OR 4.58, 95% CI 1.28\u0026ndash;16.36; p\u0026thinsp;=\u0026thinsp;0.019), Bismuth III obstruction level (OR 5.36, 95% CI 1.48\u0026ndash;19.36; p\u0026thinsp;=\u0026thinsp;0.010), ECOG 0\u0026ndash;2 (OR 0.18, 95% CI 0.06\u0026ndash;0.61; p\u0026thinsp;=\u0026thinsp;0.006), and lower pre-drainage bilirubin levels (OR 0.92, 95% CI 0.86-1.00; p\u0026thinsp;=\u0026thinsp;0.038) were independently associated with higher clinical success rates. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e presents the results of binary logistic regressions for clinical success.\u003c/p\u003e \u003cp\u003e\u003cstrong\u003eTable 4\u003c/strong\u003e\u003cstrong\u003e.\u003c/strong\u003e Uni and multivariate logistic regression for predictive factors of clinical success\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"520\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 15.9712%;\"\u003e\n \u003cp\u003eVariable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eCategory\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 31.9423%;\"\u003e\n \u003cp\u003eUnivariate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 32.8847%;\"\u003e\n \u003cp\u003eMultivariate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 18.7568%;\"\u003e\n \u003cp\u003eOR (CI 95%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 13.3712%;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 19.314%;\"\u003e\n \u003cp\u003eOR (CI 95%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 12.6924%;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"31\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 15.9712%;\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003e\u0026lt;60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003e\u0026ge;60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e0.72 (0.30-1.74)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\n \u003cp\u003e0.468\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 15.9712%;\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e0.89 (0.36-2.22)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\n \u003cp\u003e0.804\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 15.9712%;\"\u003e\n \u003cp\u003eBismuth classification\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e3.33 (1.07-10.35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\n \u003cp\u003e0.037\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e4.58 (1.28-16.36)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e0.019\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e3.92 (1.28-12.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\n \u003cp\u003e0.017\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e5.36 (1.48-19.36)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e0.010\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 15.9712%;\"\u003e\n \u003cp\u003eECOG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003e0-2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003e3-4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e0.22 (0.8-0.63)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\n \u003cp\u003e0.005\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e0.18 (0.06-0.61)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e0.006\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 15.9712%;\"\u003e\n \u003cp\u003eStent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eSEMS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003ePS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e0.31 (0.12-0.80)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\n \u003cp\u003e0.015\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e0.43 (0.14-1.29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e0.131\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 15.9712%;\"\u003e\n \u003cp\u003eCholangitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e0.66 (0.22-1.93)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\n \u003cp\u003e0.448\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.9283%;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" style=\"width: 29.8995%;\"\u003e\n \u003cp\u003eBilirubin level\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18.7568%;\"\u003e\n \u003cp\u003e0.92 (0.86-0.99)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3712%;\"\u003e\n \u003cp\u003e0.021\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 19.314%;\"\u003e\n \u003cp\u003e0.92 (0.86-1.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.6924%;\"\u003e\n \u003cp\u003e0.038\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 1.1538%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eECOG: Eastern cooperative oncology group scale; OR: odds ratio; CI: confidence interval.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatency \u0026ndash; time to recurrent biliary obstruction\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eKaplan-Meier curves and the log-rank test were applied to the categorical variables: age, gender, Bismuth level, ECOG score, and type of stent (plastic versus metallic). SEMS demonstrated significantly higher patency rates, as determined by the log-rank test (p = 0.01) (Figure 2). No significant differences were found between the groups for the other tested variables.\u003c/p\u003e\n\u003cp\u003eThe univariate Cox regression analysis showed that the PS group had a RR of 2.22 (95% CI 1.19-4.12; p = 0.012), indicating higher chances of recurrent biliary obstruction compared to the SEMS group. This finding was confirmed by multivariate analysis, with an RR of 3.17 (95% CI 1.60-6.27; p = 0.001) (Table 5).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 5 :\u0026nbsp;\u003c/strong\u003eCox proportional regression analysis for stent patency\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"520\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 87px;\"\u003e\n \u003cp\u003eVariable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 87px;\"\u003e\n \u003cp\u003eCategory\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 173px;\"\u003e\n \u003cp\u003eUnivariate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 173px;\"\u003e\n \u003cp\u003eMultivariate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 110px;\"\u003e\n \u003cp\u003eRR (CI 95%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 63px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 107px;\"\u003e\n \u003cp\u003eRR (CI 95%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 67px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"31\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd height=\"31\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 87px;\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003e\u0026lt;60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003e\u0026ge;60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e0.76 (0.42-1.40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\n \u003cp\u003e0.384\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\n \u003cp\u003e0.55 (0.29-1.04)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\n \u003cp\u003e0.065\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"35\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 87px;\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003eF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.21 (0.64-2.30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\n \u003cp\u003e0.555\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"35\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 87px;\"\u003e\n \u003cp\u003eBismuth classification\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003eII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e0.97 (0.46-2.05)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\n \u003cp\u003e0.941\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"35\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.21 (0.60-2.46)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\n \u003cp\u003e0.596\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"35\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 87px;\"\u003e\n \u003cp\u003eECOG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003e0-2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003e3-4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e0.62 (0.26-1.48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\n \u003cp\u003e0.284\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\n \u003cp\u003e0.43 (0.18-1.06)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\n \u003cp\u003e0.067\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"35\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 87px;\"\u003e\n \u003cp\u003eStent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003eSEMS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003ePS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e2.22 (1.19-4.12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\n \u003cp\u003e0.012\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\n \u003cp\u003e3.17 (1.60-6.27)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\n \u003cp\u003e0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"35\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 87px;\"\u003e\n \u003cp\u003eCholangitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e0.81 (0.42-1.58)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\n \u003cp\u003e0.541\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"35\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 87px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" style=\"width: 173px;\"\u003e\n \u003cp\u003eBilirubin level\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 110px;\"\u003e\n \u003cp\u003e1.03 (0.98-1.08)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 63px;\"\u003e\n \u003cp\u003e0.234\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 107px;\"\u003e\n \u003cp\u003e1.04 (0.99-1.09)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 67px;\"\u003e\n \u003cp\u003e0.116\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"35\" style=\"width: 0px;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eECOG: Eastern cooperative oncology group scale; RR: relative risk; CI: confidence interval.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSurvival\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe log-rank test showed higher survival rates (p = 0.022) for patients with better performance status (ECOG 0-2), and for those with bilirubin levels \u0026lt; 10 mg/dL (p = 0.003). Patients with SEMS showed a marginal, non-statistically significant difference in survival compared to those with plastic stents (p = 0.059) (Figures 3,4 and 5).\u003c/p\u003e\n\u003cp\u003eAt univariate Cox regression analysis, patients with ECOG 3-4 had a 1.81 times higher risk of death compared to those with ECOG 0-2 (95% CI 1.08-3.05; p=0.025). Additionally, for each unit increase in bilirubin, the risk of death increased by 6% (95% CI 1.02-1.09; p=0.002). Patients with PS had a 1.53 times higher risk of death compared to those with SEMS, although this difference was marginal and not statistically significant (95% CI 0.98-2.40; p = 0.062). In multivariate analysis, ECOG and bilirubin levels were confirmed as significant risk factors (Table 6).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 6 :\u0026nbsp;\u003c/strong\u003eProportional Cox regressions for survival.\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"607\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 26.2224%;\"\u003e\n \u003cp\u003eVariable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eCategory\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 26.882%;\"\u003e\n \u003cp\u003eUnivariate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 26.882%;\"\u003e\n \u003cp\u003eMultivariate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 13.8533%;\"\u003e\n \u003cp\u003eRR (CI 95%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 13.0287%;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eRR (CI 95%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 13.3586%;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"31\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 26.2224%;\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003e\u0026lt;60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003e\u0026ge;60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.08 (0.69.1.68)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\n \u003cp\u003e0.743\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 26.2224%;\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.04 (0.66-1.65)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\n \u003cp\u003e0.865\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 26.2224%;\"\u003e\n \u003cp\u003eBismuth classification\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.16 (0.66-2.02)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\n \u003cp\u003e0.604\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.17 (0.69-1.99)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\n \u003cp\u003e0.557\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 26.2224%;\"\u003e\n \u003cp\u003eECOG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003e0-2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003e3-4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.81 (1.08-3.05)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\n \u003cp\u003e0.025\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003e1.77 (1.05-2.98)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\n \u003cp\u003e0.033\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 26.2224%;\"\u003e\n \u003cp\u003eStent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eSEMS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003ePS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.53 (0.98-2.40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\n \u003cp\u003e0.062\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 26.2224%;\"\u003e\n \u003cp\u003eCholangitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.23 (0.72-2.08)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\n \u003cp\u003e0.453\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" style=\"width: 39.7458%;\"\u003e\n \u003cp\u003eBilirubin level\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.8533%;\"\u003e\n \u003cp\u003e1.06 (1.02-1.09)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.0287%;\"\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.5235%;\"\u003e\n \u003cp\u003e1.05 (1.02-1.09)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 13.3586%;\"\u003e\n \u003cp\u003e0.003\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd height=\"21\" style=\"width: 0.9895%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eECOG: Eastern cooperative oncology group scale; RR: relative risk; CI: confidence interval.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study evaluated the clinical success, stent patency, and survival outcomes of self-expanding metal stents compared to plastic stents in the palliative treatment of malignant hilar biliary obstruction. We found that SEMS demonstrated superior patency, with a significantly lower risk of recurrent biliary obstruction compared to PS. However, clinical success and survival outcomes did not differ significantly between the groups. These results align with previous studies supporting the prolonged patency of SEMS while challenging the notion of a definitive survival advantage.\u003c/p\u003e \u003cp\u003eTwo previous studies reported higher clinical success rates with SEMS (Xia: 99% vs. 71%; Sangchan: 70.4% vs. 46.3%) (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), while two others found no significant difference. (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) In our study, although SEMS was associated with higher clinical success in the univariate analysis (76.9% vs. 51.1%; p\u0026thinsp;=\u0026thinsp;0.015), this finding was not confirmed in multivariate analysis, suggesting that the apparent benefit of SEMS may be influenced by other factors, such as ECOG status. Therefore, SEMS alone does not independently predict better clinical outcomes in our cohort. However, although patients with SEMS did not experience improved clinical outcomes, they derived greater benefit from post-drainage chemotherapy. The greater concentration of ECOG 3\u0026ndash;4 patients in the PS group could also explain the more frequent use of chemotherapy in the SEMS group.\u003c/p\u003e \u003cp\u003eWe also analyzed additional variables that could correlate with clinical success. In both univariate and multivariate analyses, higher success rates were observed in patients with Bismuth II and III obstructions compared to Bismuth IV, reinforcing the challenge of effectively draining more complex hilar strictures. Better ECOG performance status (0\u0026ndash;2) was also significantly associated with clinical success, as were lower baseline bilirubin levels (\u0026lt;\u0026thinsp;10 mg/dL). Notably, for each one-unit increase in bilirubin, the likelihood of clinical success decreased by 8%. These findings highlight the role of patient-related factors in determining treatment success, rather than stent type alone.\u003c/p\u003e \u003cp\u003eSEMS demonstrated superior patency compared to PS in Kaplan-Meier analysis (median 213 days vs. 78 days), a result confirmed in both univariate and multivariate analyses. This aligns with previous reports (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e), reinforcing that SEMS reduce the likelihood of early recurrent biliary obstruction. Given the higher dysfunction rates of PS, it was expected that these patients would require more reinterventions to maintain biliary drainage. Indeed, five prior studies have reported a higher number of reinterventions in patients receiving PS (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e), while one found no significant difference. (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) However, in our study, no difference was observed in the total number of reinterventions or endoscopic reinterventions. This may be explained by the longer median survival in SEMS patients, increasing the likelihood of prosthesis revision due to occlusion or failure over time.\u003c/p\u003e \u003cp\u003eA prior study (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) reported a higher need for percutaneous transhepatic drainage (PTC) in patients with SEMS (50% vs. 22.2% for PS); however, this was not replicated in our cohort, where no significant difference was observed. This suggests that the need for additional drainage procedures may be more dependent on patient-specific factors and disease progression rather than stent selection.\u003c/p\u003e \u003cp\u003eRegarding survival, a literature review identified two studies reporting longer survival with SEMS (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), whereas three others found no significant difference. (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) In our study, univariate analysis initially showed a survival benefit for SEMS (median 301 vs. 183 days; p\u0026thinsp;=\u0026thinsp;0.023); however, this difference was not confirmed in multivariate analysis, where only a trend favoring SEMS was observed (p\u0026thinsp;=\u0026thinsp;0.059). This suggests that the initial survival advantage seen with SEMS may have been influenced by the more favorable ECOG status of this group. Complementary analyses showed that survival was significantly associated with ECOG 0\u0026ndash;2 and bilirubin levels below 10 mg/dL, with each one-point increase in bilirubin correlating with a 6% higher risk of death.\u003c/p\u003e \u003cp\u003eThis study has some limitations. It was a retrospective analysis conducted at a referral center, which may limit the generalizability of our findings to other institutions. Additionally, stent selection (SEMS vs. PS) was determined at the discretion of the endoscopist, potentially introducing selection bias. The baseline ECOG status differed between the groups, which may have influenced some of the observed differences. However, aside from ECOG, other baseline characteristics were comparable between groups.\u003c/p\u003e \u003cp\u003eEffective biliary drainage in MHBO requires careful planning, often involving a multidisciplinary evaluation including interventional radiology, surgery, clinical oncology, and endoscopy. This procedure should ideally be performed in specialized centers with experienced personnel. Several factors should be considered when selecting the optimal stent, including tumor extent, anatomical involvement, expected survival, and quality of life.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn patients with malignant hilar obstruction, SEMS demonstrated superior patency compared to PS but did not significantly impact overall survival. While univariate analysis suggested higher clinical success with SEMS, multivariate analysis showed only a marginal improvement. Clinical success was more strongly associated with better ECOG performance status and pre-drainage bilirubin levels below 10 mg/dL, while Bismuth type IV classification predicted lower success rates.\u003c/p\u003e \u003cp\u003eOverall survival, the mean number of reinterventions, and the need for percutaneous transhepatic drainage were comparable between the two groups. These findings highlight the importance of patient selection criteria beyond stent type when determining optimal biliary drainage strategies in MHBO.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003ePJOM and BM: wrote the main manuscript textDMC, JMG and RUS: Prepared figures and tablesAVSF, CMPSP, CCG, GAP, LHLT, MSL, RNM, SNG: Data collectionFMF: review and final approvalAll authors reviewed the manuscript\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eQumseya BJ, Jamil LH, Elmunzer BJ, Riaz A, Ceppa EP, Thosani NC, et al. ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction. Gastrointest Endosc. 2021;94(2):222\u0026ndash;234.e22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz J, et al. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg [Internet]. 2001 Oct 1 [cited 2025 Apr 25];234(4):507\u0026ndash;19. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://pubmed.ncbi.nlm.nih.gov/11573044/\u003c/span\u003e\u003cspan address=\"https://pubmed.ncbi.nlm.nih.gov/11573044/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXia MX, Pan YL, Cai XB, Wu J, Gao DJ, Ye X, et al. Comparison of endoscopic bilateral metal stent drainage with plastic stents in the palliation of unresectable hilar biliary malignant strictures: Large multicenter study. Digestive Endoscopy. 2021;33(1):179\u0026ndash;89.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTakahashi E, Fukasawa M, Sato T, Takano S, Kadokura M, Shindo H, et al. Biliary drainage strategy of unresectable malignant hilar strictures by computed tomography volumetry. World J Gastroenterol. 2015;21(16):4946\u0026ndash;53.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVienne A, Hobeika E, Gouya H, Lapidus N, Fritsch J, Choury AD, et al. Prediction of drainage effectiveness during endoscopic stenting of malignant hilar strictures: The role of liver volume assessment. Gastrointest Endosc. 2010;72(4):728\u0026ndash;35.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIwasaki A, Kubota K, Kurita Y, Hasegawa S, Fujita Y, Kagawa K, et al. The placement of multiple plastic stents still has important roles in candidates for chemotherapy for unresectable perihilar cholangiocarcinoma. J Hepatobiliary Pancreat Sci. 2020;27(10):700\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChiba M, Kato M, Kinoshita Y, Shimamoto N, Tomita Y, Abe T, et al. Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis. Sci Rep. 2020;10(1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSangchan A, Kongkasame W, Pugkhem A, Jenwitheesuk K, Mairiang P. Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: A randomized controlled trial. Gastrointest Endosc. 2012;76(1):93\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChoi JH, Lee SH, You MS, Shin B sup, Choi YH, Kang J, et al. Step-wise endoscopic approach to palliative bilateral biliary drainage for unresectable advanced malignant hilar obstruction. Sci Rep. 2019;9(1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2018;25(1):17\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMartins BC, Perez CA, Ruas JN, Bento LH, Mendon\u0026ccedil;a EQ, de Paulo GA, et al. Results of endoscopic biliary drainage in patients with malignant hilar stricture. Clinics. 2023;78.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSawas T, Al Halabi S, Parsi MA, Vargo JJ. Self-expandable metal stents versus plastic stents for malignant biliary obstruction: A meta-analysis. Vol. 82, Gastrointestinal Endoscopy. Mosby Inc.; 2015. p. 256\u0026ndash;267.e7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoole H, Dharmapuri S, Duvvuri A, Dharmapuri S, Boddireddy R, Moole V, et al. Endoscopic versus Percutaneous Biliary Drainage in Palliation of Advanced Malignant Hilar Obstruction: A Meta-Analysis and Systematic Review. Can J Gastroenterol Hepatol [Internet]. 2016 [cited 2025 Apr 25];2016. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://pubmed.ncbi.nlm.nih.gov/27648439/\u003c/span\u003e\u003cspan address=\"https://pubmed.ncbi.nlm.nih.gov/27648439/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFukasawa M, Takano S, Shindo H, Takahashi E, Sato T, Enomoto N. Endoscopic biliary stenting for unresectable malignant hilar obstruction. Vol. 10, Clinical Journal of Gastroenterology. Springer Tokyo; 2017. p. 485\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTringali A, Boškoski I, Costamagna G. Endoscopic Stenting in Hilar Cholangiocarcinoma: When, How, and How Much to Drain? 2019.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZorr\u0026oacute;n Pu L, De Moura EGH, Bernardo WM, Baracat FI, Mendon\u0026ccedil;a EQ, Kondo A, et al. Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol [Internet]. 2015 Dec 21 [cited 2025 Apr 25];21(47):13374\u0026ndash;85. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://pubmed.ncbi.nlm.nih.gov/26715823/\u003c/span\u003e\u003cspan address=\"https://pubmed.ncbi.nlm.nih.gov/26715823/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, et al. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: A randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013;20(2):214\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAngsuwatcharakon P, Kulpatcharapong S, Chuncharunee A, Khor C, Devereaux B, Moon JH, et al. The updated Asia-Pacific consensus statement on the role of endoscopic management in malignant hilar biliary obstruction. Endosc Int Open. 2024;\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIsayama H, Hamada T, Fujisawa T, Fukasawa M, Hara K, Irisawa A, et al. TOKYO criteria 2024 for the assessment of clinical outcomes of endoscopic biliary drainage. Digestive Endoscopy. John Wiley and Sons Inc; 2024.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKadayifci A, Atar M, Forcione DG, Casey BW, Kelsey PB, Brugge WR. Radiofrequency ablation for the management of occluded biliary metal stents. Endoscopy [Internet]. 2016 Dec 1 [cited 2025 Apr 25];48(12):1096\u0026ndash;101. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://pubmed.ncbi.nlm.nih.gov/27716861/\u003c/span\u003e\u003cspan address=\"https://pubmed.ncbi.nlm.nih.gov/27716861/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy [Internet]. 1993 [cited 2025 Apr 22];25(3):213\u0026ndash;8. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://pubmed.ncbi.nlm.nih.gov/7686100/\u003c/span\u003e\u003cspan address=\"https://pubmed.ncbi.nlm.nih.gov/7686100/\" targettype=\"URL\" 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":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-6537218/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6537218/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThis retrospective study compared plastic stents (PS) and self-expanding metal stents (SEMS) in 86 patients with unresectable malignant hilar biliary obstruction (MHBO) treated between 2015 and 2022. In univariate analysis, SEMS were associated with higher clinical success (76.9% vs. 51.1%) and significantly longer stent patency (median 213 vs. 78 days) compared to PS. They also showed a lower risk of recurrent biliary obstruction. However, overall survival did not differ significantly between groups. Multivariate analysis revealed that better ECOG performance status and lower bilirubin levels, rather than stent type, predicted improved clinical outcomes. SEMS offer superior durability, but stent selection should be guided by individual patient characteristics.\u003c/p\u003e","manuscriptTitle":"Clinical Outcomes of Plastic versus Self-Expanding Metal Stents in Malignant Hilar Biliary Obstruction","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-13 12:13:31","doi":"10.21203/rs.3.rs-6537218/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"bcfc6177-0374-4135-a04a-72c1291fd335","owner":[],"postedDate":"May 13th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":48283516,"name":"Health sciences/Gastroenterology"},{"id":48283517,"name":"Health sciences/Oncology"}],"tags":[],"updatedAt":"2025-06-03T07:53:55+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-13 12:13:31","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6537218","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6537218","identity":"rs-6537218","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}