Evaluation of Intravenous Infusion Port Abdominal Wall Implantation Technology for Delivery of Intraperitoneal Chemotherapy in Advanced-Stage Ovarian Cancer

Evaluation of Intravenous Infusion Port Abdominal Wall Implantation Technology for Delivery of Intraperitoneal Chemotherapy in Advanced-Stage Ovarian Cancer | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Evaluation of Intravenous Infusion Port Abdominal Wall Implantation Technology for Delivery of Intraperitoneal Chemotherapy in Advanced-Stage Ovarian Cancer Sirui Hu, Jingyi Zhang, Lingxiao Zhang, Jiao Yang, Liang Zhao, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6642224/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 study evaluated the safety and efficacy of a novel intravenous infusion port abdominal wall implantation technique for intraperitoneal chemotherapy in advanced-stage ovarian cancer (FIGO III-IV). In a single-arm clinical trial of 42 patients, the implantation success rate reached 100%, with 97.6% of patients completing at least four treatment cycles. The overall response rate (CR+PR) was 69.0%. Common complications included puncture site pain (95.2%), abdominal distension (42.9%), and lumen blockage (14.3%), all of which were mild and manageable. Both physician and patient satisfaction scores exceeded 91 points. The technique eliminated the need for laparotomy, minimized trauma, simplified procedures, and ensured long-term safety, making it particularly suitable for peritoneal metastasis and pelvic recurrence. Limitations included the small sample size and lack of a control group, warranting future multicenter validation. This approach provides a feasible option for intraperitoneal chemotherapy in primary care settings, potentially optimizing treatment strategies for advanced ovarian cancer. Infusion port Abdominal wall implantation Ovarian cancer Intraperitoneal perfusion chemotherapy Figures Figure 1 Figure 2 1. Introduction Intraperitoneal (IP) chemotherapy has emerged as a promising treatment option for advanced epithelial ovarian cancer (EOC), particularly in the case of patients with extensive peritoneal dissemination [ 1 ]. This advancement has prompted the development of various perfusion methods and devices aimed at minimizing the risk of infection and complications. Researchers in China have adopted the use of infusion ports for administration of IP chemotherapy. An earlier study by Tang et al. [ 2 ] demonstrated higher initial puncture success and treatment completion rates with this approach compared to traditional paracentesis. This technique may be particularly beneficial for patients undergoing prolonged chemotherapy regimens. In 2018, our department adopted intravenous infusion port technology for paracentesis in patients diagnosed with ovarian cancer, which allowed for abdominal wall implantation of infusion ports and periodic IP treatment. The current investigation involved a single-arm clinical study on 42 patients with FIGO stage III-IV ovarian cancer, aimed at evaluating the feasibility and safety of this technique. The results demonstrated a high success rate in port placement with minimal complications. This method simplified the overall procedure, reduced the risk of infection, and facilitated easy removal of the device. The collective findings indicate that this approach has the potential to improve the effectiveness of IP therapy for advanced ovarian cancer and supports its adoption in primary care settings. 2. Materials and methods 2.1. Methods and ethics This is a single-arm study. Statistical results were analyzed using SPSS 20.0 software. The analysis focused on data related to patient demographics, disease characteristics, treatment regimens, and outcomes, utilizing descriptive statistics.Clinical trial number: not applicable. A high pressure-resistant infusion port type central venous catheter and accessories were employed (specification/model 8808561). Prior to surgical intervention, it was essential to exclude the presence of coagulation abnormalities, intestinal obstructions, infections, and extensive abdominal adhesion fixation. All procedures were conducted in accordance with the relevant guidelines and regulations. The study was approved by Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University. Informed consent was obtained from all participants. 2.2. Statistical criteria Ovarian cancer was diagnosed based on the following criteria: 1) pathology or cytology (ovarian malignant tumor) based on the 2018 FIGO staging guidelines; 2) evidence of pelvic abdominal recurrence or metastasis of disease; 3) need for systemic chemotherapy. The treatment protocol entailed administration of intravenous albumin-bound paclitaxel at a dosage of 100 mg/kg on d1 and d8, along with cisplatin 80 mg/m 2 or carboplatin 400 mg delivered intraperitoneally on d1. The regimen is repeated every three weeks, totaling six cycles, and at least the treatment for the first cycle must be completed. The treatment cohort comprised 56 patients, including 42 with adverse events, and doctor-patient satisfaction scores were recorded. The primary endpoints were success rate and adverse events. Secondary observation indicators included the effectiveness of port placement with systemic treatment and doctor-patient satisfaction. The study was performed in accordance with the guidelines of RECIST standard version 1.1 [3]. 2.3. Key technical steps The primary technical steps of the procedure were as follows: 1) paracentesis to establish artificial ascites, 2) implantation of an intravenous infusion port within the abdominal wall, and 3) peritoneal perfusion chemotherapy. The abdominal wall implantation of the first intravenous infusion port could be completed concurrently with the surgical intervention, but was limited to simple infusions of low-irritation chemotherapy drugs, such as cisplatin. In cases where the perfusion drugs adversely affected healing of the abdominal wall wound, delaying perfusion therapy until the day after the operation was recommended. During periodic perfusion therapy, normal saline was infused in volumes up to 1500 mL both prior to and after drug administration, serving to establish artificial ascites and promote intraperitoneal diffusion and metabolic absorption of the drug. Following the completion of perfusion, the port body and abdominal wall tubes were blocked with heparin sodium. 2.4. Postoperative care and treatment of complications A specialized registry was issued after surgery to record the time and disease status associated with patient port placement, alongside detailed nursing operations. The registry additionally facilitated the conduction of satisfaction surveys and follow-up communication via telephone for first-time users. The duration of care and treatment of the port during perfusion chemotherapy were clearly outlined. In instances where the port was retained after periodic perfusion, it was recommended that the ordinary intravenous infusion port be maintained at least once a month and the high pressure-resistant intravenous infusion port maintained at least once every 3 months. In the event of serious complications, such as postoperative infection, intestinal obstruction, or abdominal wall implant transfer, the intravenous infusion port device was removed. In case of intravenous infusion port joint displacement or port body interface detachment, attempts were made to adjust or reconnect the device if anatomically feasible. 3. Results 3.1. Case statistics A total of 42 patients were recruited for this study. The baseline characteristics, treatment status, and doctor-patient satisfaction statistics are shown in Table 1 , highlighting a port placement success rate of 100%. The overall treatment response rate, including complete response (CR), partial response (PR) and stable disease (SD), was 85.7%. The average operative time for the first port placement procedure was 67 minutes. Each session of periodic intraperitoneal chemotherapy was completed by the healthcare provider in less than 15 minutes. After placement of the port, the patients were capable of self-care. The average duration of port dwell time was 8.9 months. Table 1 Information statistics regarding IP treatment in our study sample of 42 ovarian cancer patients Project Number of cases Percentage (%) TNM 42 100 Ⅲc 8 19.1 Ⅳ 34 80.9 Number of successful catheters 42 100 Number of lines of treatment 42 100 First-line (first treatment after relapse and metastasis) 27 64.3 Second-line (2 treatments after the first treatment failure) 11 26.2 Third-line and above (2 or more regimens have been performed) 4 9.5 Completion cycle 42 100 1 Cycle 1 2.4 4 Cycle 5 11.9 6 Cycle 37 88.1 Infusion of drugs 42 100 Cisplatin 36 90.5 Carboplatin 4 9.5 Evaluation 42 100% CR 8 19 PR 21 50 SD 7 16.7 PD 5 11.9 Withdraw from 1 2.4 Satisfaction score (100 points) Medical satisfaction 56 92.4 Patient satisfaction 42 91.5 3.2. Adverse events The following adverse events were recorded: (1) pain at the puncture site with an incidence rate of 40/42 (95.2%), Grade CTCAE1, which self-remitted within two days post-surgery; (2) abdominal distension with an incidence rate of 18/42 (42.9%), Grade CTCAE1, which resolved spontaneously from 5 to 7 days after surgery; (3) abdominal pain with an incidence rate of 7/42 (16.7%), Grade CTCAE1, which resolved spontaneously after 5 days (to rule out the possibility of intestinal obstruction, all patients underwent additional abdominal vertical position X-ray examinations); (4), fever with an incidence rate of 4/42 (9.5%), Grade CTCAE2, which was relieved through self-administration of ibuprofen; (5), infection with an incidence rate of 1/42 (2.4%), Grade CTCAE3. In this case, the patient underwent multi-cycle treatment and had received five sessions of traditional peritoneal puncture perfusion therapy before enrollment, with a traditional abdominal indwelling tube in place for more than one month. Considering the infection risks due to repeated abdominal punctures and the presence of a long-term external indwelling catheter, the intravenous infusion port device was removed, and systemic anti-infection treatment was initiated, following which the patient was discharged after recovery. (6) Lumen blockage was an adverse event in 6/42 patients (14.3%), Grade CTCAE1, which returned to normal after flushing the tube with heparin sodium. (7) Port body displacement was reported in 1/42 patients (2.4%). The patient completed six cycles of perfusion treatment, after which the infusion port was removed (details in Fig. 2 ). 4. Discussion The increasing focus on the application of hyperthermic intraperitoneal chemotherapy (HIPEC) is reflected by the findings of Wu et al. [ 4 ] and Neveu et al. [ 5 ], which clearly demonstrate potential benefits in the management of ovarian cancer. While thermal perfusion chemotherapy is recognized as an effective option for the treatment of peritoneal malignancies, not all medical units are equipped with well-established thermal perfusion capabilities. In many primary medical units, traditional single-point peritoneal paracentesis and perfusion chemotherapy continue to be widely employed due to their low cost and ease of use, allowing for rapid catheter insertion. However, the risk of intestinal perforation associated with traditional single-point puncture poses a significant challenge. Due to the repeated, blind puncturing required for traditional single-point paracentesis, this approach increases the workload and operational risk for physicians, which is unfavorable for patients requiring repeated perfusion as part of a periodic treatment regimen. Additionally, long-term retention of catheters escalates the risk of abdominal infections. To address these limitations, we incorporated intravenous infusion port technology into the traditional peritoneal perfusion treatment protocol. The catheter tip was placed within the peritoneal cavity, while the port body was implanted subcutaneously in the abdominal wall, creating a closed, extracorporeal perfusion pathway that facilitated repeated peritoneal perfusion treatments. Furthermore, the peritoneal reabsorptive function, drug metabolism, and artificial ascites facilitated the cycle of repeated peritoneal perfusion therapy. Ongoing research and development are directed towards improving IP chemotherapy devices and methods. According to data obtained by the group of Padmakumar et al. [ 6 ], treatment toxicity, patient inconvenience, and additional costs associated with the use of IP chemotherapy vary considerably across institutions. The lack of a robust and clinically feasible intra-abdominal delivery system hinders the effective transport of chemotherapy drugs into the abdominal cavity of patients with ovarian cancer, leading to underutilization of IP chemotherapy. The development of a non-ductal IP drug delivery system that preserves peritoneal drug levels while reducing systemic levels could offer a significant survival advantage as a treatment strategy that improves patient compliance. Chambers et al. [ 7 ] demonstrated that surgical peritoneal port complications accounted for 20.8% of the cases in which intraperitoneal perfusion therapy was not utilized. Previous studies by Buckingham et al. [ 8 ] and Bakrin and Gladieff [ 9 ] showed that commonly used peritoneal chemotherapy devices, as well as different placement materials, techniques, and device structures have their own distinct advantages and disadvantages. Catheter placement can be performed either during or after surgery. However, there are specific requirements regarding the placement method, timing, and site, potentially curtailing the application of IP chemotherapy extent. Catheterization techniques present various inherent limitations, including specific requirements for the placement method, timing, and site, which may restrict the use of IP chemotherapy to some extent. Clinical considerations should encompass the cost of catheters and the management of associated complications. As a result, the promotion and widespread application of many port devices and technologies at the grassroots level face significant restrictions. The subcutaneous implantation of an intravenous infusion port offers a promising alternative. This method is particularly compatible with the characteristics of intermittent abdominal perfusion therapy, effectively overcoming the limitations of traditional single-point abdominal puncture, which fails to maintain long-term drug retention. Furthermore, it avoids the disadvantages of open abdominal catheterization, such as increased trauma and procedural complexity. This technique is associated with a high success rate, fewer complications, and simplified procedures for healthcare providers, additionally reducing the risk of patient infection and facilitating easier device removal. Such improvements in the method promote the utilization of IP treatment for advanced ovarian cancer and facilitate its implementation in primary medical facilities. There are two opposing viewpoints to IP chemotherapy. Wang et al. [ 10 ] argued that IP combined with intravenous chemotherapy requires substantially more time as well as human and material resources than intravenous administration alone. The group additionally highlighted the potential for increased chemotherapy-related toxicity and complications linked to catheter placement and drug perfusion. On the other hand, Yeku and co-workers [ 11 ] maintain that these challenges can be overcome, asserting that IP therapy ultimately offers significant benefits. During the course of technical development, we selected a high-resistance, triple-chamber valve reflux device to reduce the risk of intravenous infusion port occlusion caused by ascites crystallization, chemotherapeutic drug deposition, and intra-abdominal fibrin sheath formation. Studies by the research teams of Manning-Geist et al. [ 12 ] and Fayzullin et al. [ 13 ] have highlighted common complications linked to infusion ports, including displacement, catheter distortion or damage, tube blockage, thrombosis, and infection. We observed similar complications in the application of this technology, such as lumen blockage (6/42, 14.3%) and port body displacement (1/42, 2.4%). Due to the focus on details such as the subcutaneous catheter position and port connection, and the fact that these procedures are carried out under the assistance of technically proficient medical staff, the incidence of other catheter-related complications has been effectively reduced. The single case of abdominal infection was linked to high risk factors in the patient’s retrospective medical history, indicating the necessity for comprehensive evaluation of abdominal status for patients undergoing repeated peritoneal punctures and external abdominal catheterization before the application of this technique, which can effectively reduce the likelihood of abdominal infection. This investigation was initiated in February 2019 and continued for over 5 years at the time of data analysis. Throughout this period, there were no cases of complete tube blockage that led to treatment interruption. The average retention time for enrolled patients exceeded 7 months, which fully met the needs of periodic peritoneal perfusion treatment in internal medicine. In addition to catheter complications, we observed gastrointestinal reactions, myelosuppression, and other chemotherapy-related adverse events, but these were not classified as technical complications. To date, no randomized trials have established the equivalence of intraperitoneal carboplatin administration to that of intraperitoneal cisplatin in terms of survival impact. Cadoo et al. [ 14 ] reported that cisplatin infusion chemotherapy is considered effective with a low incidence of adverse reactions. However, other researchers, such as the group of Hasegawa et al. [ 15 ], favor the use of carboplatin, based on studies suggesting that intraperitoneal carboplatin may be equally effective as cisplatin. Consequently, the platinum drugs for intraperitoneal perfusion were not strictly defined in this study. Due to the limited sample size, differences in postoperative adverse effects resulting from cisplatin and carboplatin could not be evaluated. The present study has a number of limitations that should be acknowledged. The observation period is short, which could lead to the overlooking of certain complications that were not statistically observed, such as catheter shedding and port body turnover. Additionally, complication data may be subject to bias and errors due to the small sample size. This study is a single-arm experiment, lacking a set control group, which may limit evaluation of the authenticity and reliability of the intervention effect. The current intravenous infusion port device is more expensive than the traditional single-point abdominal puncture, necessitating the careful selection of appropriate patients. Furthermore, the procedure requires a physician with substantial experience in peritoneal puncture to avoid potential complications. A skilled team is essential for the effective and safe implementation of the intravenous infusion port technology. Therefore, it is crucial to not only identify the patient population suitable for intraperitoneal chemotherapy but also devise personalized care strategies to enhance their quality of life [ 16 ]. Declarations Acknowledgments The authors thank Dr. Gang Xu for his excellent technical assistance and International Science Editing ( http://www.internationalscienceediting.com ) for editing this manuscript. Funding This study was supported by four funding grants: Central University Basic Research Fund of China (xzy012021061), Xi'an Jiaotong University, 2024 Undergraduate Education Reform Research Project (24ZK29Y)，Natural Science Foundation of Shaanxi Province (2020 JQ-517), and General Project of Clinical Research of The First Affiliated Hospital of Xi'an Jiaotong University (XJT U1AF-CRF-2017-022). Author information Author notes Sirui Hu and Jingyi Zhang have contributed equally to this work. Authors and Affiliations Department of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, PR China Sirui Hu, Jingyi Zhang, Lingxiao Zhang, Jiao Yang, Xiaoai Zhang, Jin Yang and Danfeng Dong, Le Wang Department of General Surgery, HeYang Hospital of Traditional Chinese Medicine, Weinan, Shaanxi, PR China Liang Zhao Physical Medicine and Rehabilitation, Honghui Hospital Affiliated to Xi ’ an Jiaotong University, Xi’an, Shaanxi, PR China Lina Wang Contributions Sirui Hu, Jingyi Zhang and Le Wang wrote the manuscript. Lingxiao Zhang, and Jiao Yang analyzed the data. Liang Zhao and Lina Wang performed data acquisition and curation. Le Wang, Xiaoai Zhang, Jin Yang and Danfeng Dong conceptualized the idea and designed the research. All authors interpreted the data, critically reviewed the manuscript, had the opportunity to make revisions and approved the final version for submission. Corresponding authors Correspondence to Le Wang. Ethics declarations Conflict of interests The authors declare no competing interests. The authors informed consent was obtained from all individual participants included in the study. Ethical approval Clinical trial number: Not applicable.This study was a retrospective evaluation of a new medical technology implementation and did not constitute a clinical trial. The abdominal wall implantation technique for intraperitoneal chemotherapy delivery was approved as a new medical technology project by the First Affiliated Hospital of Xi'an Jiaotong University (Approval No. XJYFY-2018-N5) in October 2018. The Ethics Committee of the same institution reviewed and approved both the technical protocol and patient informed consent documents. This study was approved by the Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2020LSK-087). Written informed consent was obtained from all individual participants included in the study.All participants provided consent for the publication of anonymized data. Rights and permissions Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. References A. Ogasawara, H. Matsushita, T.Z. Tan, D. Shintani, J. Ye, S. Nagao, et al. Immunological impact of intraperitoneal and intravenous chemotherapy in ovarian cancer, translational analyses of the phase 3 iPocc trial. Gynecol. Oncol. 191 (2024) 124–131. Q. Tang, M. Huang, J. Zhang, Z. Huang, L. Wang, Z. Gong, et al. Comparative survival outcomes of hyperthermic intraperitoneal chemotherapy, intraperitoneal chemotherapy and intravenous chemotherapy for primary advanced ovarian cancer: a network meta-analysis. J. Clin. Med. 12 (3) (2023) 1111. L.H. Schwartz, S. Litière, E. de Vries, R. Ford, S. Gwyther, S. Mandrekar, et al. RECIST 1.1-Update and clarification: from the RECIST committee. Eur. J. Cancer. 62 (2016) 132–137. M.F. Wu, L.J. Wang, Y.F. Ye, C.H. Liu, H.W. Lu, T.T. Yao, et al. Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial. BMJ Open. 11 (12) (2021) e046415. J. Neveu, E. Tremblay, F. Mercier, S. Garneau, B. Cormier. Developing a hyperthermic intraperitoneal chemotherapy (HIPEC) gynecologic oncology program: a Canadian experience. Int. J. Gynecol. Cancer 33 (12) (2023) 1957–1965. S. Padmakumar, N. Parayath, F. Leslie, S.V. Nair, D. Menon, M.M. Amiji. Intraperitoneal chemotherapy for ovarian cancer using sustained-release implantable devices. Expert. Opin. Drug. Deliv. 15 (5) (2018) 481–494. L.M. Chambers, J. Son, M. Radeva, R. DeBernardo. Evaluation of non-completion of intraperitoneal chemotherapy in patients with advanced epithelial ovarian cancer. J. Gynecol. Oncol. 30 (6) (2019) e93. L. Buckingham, A. Koenig, E.M. Ko, C.M. Brensinger, N. Latif, C. Hummel, et al. Low rate of intraperitoneal port placement in ovarian cancer patients, a population-based assessment. Int. J. Gynecol. Cancer 29 (7) (2019) 1177–1181. N. Bakrin, L. Gladieff. Malignant epithelial ovarian cancer: Role of intra peritoneal chemotherapy and hyperthermic intra peritoneal chemotherapy (HIPEC): Article drafted from the French Guidelines in oncology entitled "Initial management of patients with epithelial ovarian cancer" developed by FRANCOGYN, CNGOF, SFOG, GINECO-ARCAGY under the aegis of CNGOF and endorsed by INCa. Gynecol. Obstet. Fertil. Senol. 47 (2) (2019) 214–221. J.Y. Wang, M. Gross, R.R. Urban, S. Jorge. Intraperitoneal and hyperthermic intraperitoneal chemotherapy for the treatment of ovarian cancer. Curr. Treat. Options Oncol. 25 (3) (2024) 313–329. O.O. Yeku. Intraperitoneal therapy for ovarian cancer – some answers, more questions, and missed opportunities. NEJM Evid. 2 (5) (2023) EVIDe2300048. B.L. Manning-Geist, M.W. Sullivan, V. Sarda, A.A. Gockley, M.G. Del Carmen, U. Matulonis, et al. Disease distribution at presentation impacts benefit of IP chemotherapy among patients with advanced-stage ovarian cancer. Ann. Surg. Oncol. 28 (11) (2021) 6705–6713. A. Fayzullin, A. Bakulina, K. Mikaelyan, A. Shekhter, A. Guller. Implantable drug delivery systems and foreign body reaction: traversing the current clinical landscape. Bioengineering (Basel) 8 (12) 2021 205. K.A. Cadoo, R.N. Grisham, R.E. O'Cearbhaill, N.N. Boucicaut, M. Henson, A. Iasonos, et al. A phase 1 dose-escalation study of intraperitoneal cisplatin, intravenous/intraperitoneal paclitaxel, bevacizumab, and olaparib for newly diagnosed ovarian cancer. Gynecol. Oncol. 157 (1) (2020) 214–221. K. Hasegawa, M. Shimada, S. Takeuchi, H. Fujiwara, Y. Imai, N. Iwasa, et al. A phase 2 study of intraperitoneal carboplatin plus intravenous dose-dense paclitaxel in front-line treatment of suboptimal residual ovarian cancer. Br. J. Cancer 122 (6) (2020) 766–770. L. Foster, C. Girgis, A. Kirby, P. Harnett, A. Brand. The use of intraperitoneal chemotherapy for advanced ovarian cancer – The experience of a tertiary referral centre. Aust. N Z J Obstet. Gynaecol. 64 (3) (2024) 239–244. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6642224","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":473434810,"identity":"f7920752-d704-42dd-bc58-e3f79fd6867e","order_by":0,"name":"Sirui Hu","email":"","orcid":"","institution":"The First Affiliated Hospital of Xi’an Jiaotong University","correspondingAuthor":false,"prefix":"","firstName":"Sirui","middleName":"","lastName":"Hu","suffix":""},{"id":473434811,"identity":"ac134301-3311-44bc-97bc-c1be09a56ccb","order_by":1,"name":"Jingyi Zhang","email":"","orcid":"","institution":"The First Affiliated Hospital of Xi’an Jiaotong University","correspondingAuthor":false,"prefix":"","firstName":"Jingyi","middleName":"","lastName":"Zhang","suffix":""},{"id":473434813,"identity":"96212a10-8312-487a-be88-27a6158ddbeb","order_by":2,"name":"Lingxiao Zhang","email":"","orcid":"","institution":"The First Affiliated Hospital of Xi’an Jiaotong University","correspondingAuthor":false,"prefix":"","firstName":"Lingxiao","middleName":"","lastName":"Zhang","suffix":""},{"id":473434814,"identity":"4bb5022e-983d-4b73-bcf7-cf86ba0ebacc","order_by":3,"name":"Jiao Yang","email":"","orcid":"","institution":"The First Affiliated Hospital of Xi’an Jiaotong University","correspondingAuthor":false,"prefix":"","firstName":"Jiao","middleName":"","lastName":"Yang","suffix":""},{"id":473434815,"identity":"98f02126-8e86-4b45-ac13-831ea43cf284","order_by":4,"name":"Liang Zhao","email":"","orcid":"","institution":"HeYang Hospital of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Liang","middleName":"","lastName":"Zhao","suffix":""},{"id":473434816,"identity":"fa666131-e007-4e3e-a046-1e97b27d3a37","order_by":5,"name":"Lina Wang","email":"","orcid":"","institution":"Honghui Hospital Affiliated to Xi’an Jiaotong University","correspondingAuthor":false,"prefix":"","firstName":"Lina","middleName":"","lastName":"Wang","suffix":""},{"id":473434817,"identity":"4c23e507-d7ba-4764-ae19-f2e946a981cc","order_by":6,"name":"Xiaoai Zhao","email":"","orcid":"","institution":"The First Affiliated Hospital of Xi’an Jiaotong University","correspondingAuthor":false,"prefix":"","firstName":"Xiaoai","middleName":"","lastName":"Zhao","suffix":""},{"id":473434818,"identity":"974c8d14-f630-4869-be2e-ac609312ff5f","order_by":7,"name":"Jin Yang","email":"","orcid":"","institution":"The First Affiliated Hospital of Xi’an Jiaotong University","correspondingAuthor":false,"prefix":"","firstName":"Jin","middleName":"","lastName":"Yang","suffix":""},{"id":473434819,"identity":"f0c2b5e0-82fd-476e-9c92-bd568fbd796f","order_by":8,"name":"Danfeng Dong","email":"","orcid":"","institution":"The First Affiliated Hospital of Xi’an Jiaotong University","correspondingAuthor":false,"prefix":"","firstName":"Danfeng","middleName":"","lastName":"Dong","suffix":""},{"id":473434820,"identity":"bb68843a-6fea-4bc3-ba75-ae52c6853283","order_by":9,"name":"Le Wang","email":"data:image/png;base64,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","orcid":"","institution":"The First Affiliated Hospital of Xi’an Jiaotong University","correspondingAuthor":true,"prefix":"","firstName":"Le","middleName":"","lastName":"Wang","suffix":""}],"badges":[],"createdAt":"2025-05-12 02:38:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6642224/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6642224/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":85269389,"identity":"7cbcf0bc-9bc9-4efa-8b2b-4802823133a0","added_by":"auto","created_at":"2025-06-24 06:10:38","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":6722534,"visible":true,"origin":"","legend":"\u003cp\u003eA technique based on intravenous infusion port abdominal wall implantation for administration of intraperitoneal infusion chemotherapy in patients with ovarian cancer\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNotes:\u003c/strong\u003e a. Paracentesis was performed at the anti-McBurney point; b. A puncture needle connected to normal saline was inserted percutaneously, allowing for a linear drip; c. Artificial ascites was successfully established; d. A guidewire was inserted into the peritoneal cavity for a distance of 20 cm; e. The puncture needle was withdrawn; f. The skin at the puncture site was dilated approximately 0.5 cm along the direction of the port and a moderate incision made in the abdominal wall to create a beveled surface, thereby preventing kinking of the catheter; g. A puncture sheath was inserted along the guidewire; h. The dilator and guidewire were removed allowing for the insertion of the catheter through the tear-away sheath to a depth of approximately 20 cm; i. Local anesthesia was administered; j. A subcutaneous pocket was created to accommodate the size of the port; k. A tunneling needle was inserted from the midpoint of the port incision towards the original puncture site to create a subcutaneous tunnel; l. The distal end of the catheter was connected to the tunneling needle, enabling the catheter to be pulled through the subcutaneous tunnel to the port site. A catheter lock was placed, following which the catheter was trimmed, connected to the port, and secured using the catheter lock. The port was aligned, the catheter arranged to avoid kinking, and a non-coring needle used to puncture the port for saline injection to confirm patency; m. The port incision and puncture site were subsequently sutured; n. The abdominal wall skin after port placement; o. For intraperitoneal perfusion treatment, a non-coring needle was used to puncture the port and the infusion set connected for drug administration. Heparin sodium was administered to seal the port and abdominal wall tubing after treatment to prevent occlusion.\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6642224/v1/aca9e6b532191c6d08168399.jpg"},{"id":85269391,"identity":"7805b0db-8cc5-4ae7-84af-9b9a9fd8d133","added_by":"auto","created_at":"2025-06-24 06:10:38","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":463113,"visible":true,"origin":"","legend":"\u003cp\u003eAdverse events associated with implantable port placement in the abdominal wall for intraperitoneal perfusion therapy\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6642224/v1/6732956c2cae3d2955afd45f.jpg"},{"id":90967079,"identity":"70e34660-aef3-4f8c-8a7d-db92d25b75a7","added_by":"auto","created_at":"2025-09-10 06:47:10","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":7996633,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6642224/v1/fe0626f6-8cb2-4979-af88-a8938cf367a8.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Evaluation of Intravenous Infusion Port Abdominal Wall Implantation Technology for Delivery of Intraperitoneal Chemotherapy in Advanced-Stage Ovarian Cancer","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eIntraperitoneal (IP) chemotherapy has emerged as a promising treatment option for advanced epithelial ovarian cancer (EOC), particularly in the case of patients with extensive peritoneal dissemination [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. This advancement has prompted the development of various perfusion methods and devices aimed at minimizing the risk of infection and complications. Researchers in China have adopted the use of infusion ports for administration of IP chemotherapy. An earlier study by Tang et al. [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] demonstrated higher initial puncture success and treatment completion rates with this approach compared to traditional paracentesis. This technique may be particularly beneficial for patients undergoing prolonged chemotherapy regimens.\u003c/p\u003e \u003cp\u003eIn 2018, our department adopted intravenous infusion port technology for paracentesis in patients diagnosed with ovarian cancer, which allowed for abdominal wall implantation of infusion ports and periodic IP treatment. The current investigation involved a single-arm clinical study on 42 patients with FIGO stage III-IV ovarian cancer, aimed at evaluating the feasibility and safety of this technique. The results demonstrated a high success rate in port placement with minimal complications. This method simplified the overall procedure, reduced the risk of infection, and facilitated easy removal of the device. The collective findings indicate that this approach has the potential to improve the effectiveness of IP therapy for advanced ovarian cancer and supports its adoption in primary care settings.\u003c/p\u003e"},{"header":"2. Materials and methods","content":"\u003ch2\u003e\u003cem\u003e2.1. Methods and ethics\u003c/em\u003e\u003c/h2\u003e\n\u003cp\u003eThis is a single-arm study. Statistical results were analyzed using SPSS 20.0 software. The analysis focused on data related to patient demographics, disease characteristics, treatment regimens, and outcomes, utilizing descriptive statistics.Clinical trial number: not applicable.\u003c/p\u003e\n\u003cp\u003eA high pressure-resistant infusion port type central venous catheter and accessories were employed (specification/model 8808561). Prior to surgical intervention, it was essential to exclude the presence of coagulation abnormalities, intestinal obstructions, infections, and extensive abdominal adhesion fixation.\u003c/p\u003e\n\u003cp\u003eAll procedures were conducted in accordance with the relevant guidelines and regulations. The study was approved by Ethics Committee of the First Affiliated Hospital of Xi\u0026apos;an Jiaotong University. Informed consent was obtained from all participants.\u003c/p\u003e\n\u003ch2\u003e\u003cem\u003e2.2. Statistical criteria\u003c/em\u003e\u003c/h2\u003e\n\u003cp\u003eOvarian cancer was diagnosed based on the following criteria: 1) pathology or cytology (ovarian malignant tumor) based on the 2018 FIGO staging guidelines; 2) evidence of pelvic abdominal recurrence or metastasis of disease; 3) need for systemic chemotherapy. The treatment protocol entailed administration of intravenous albumin-bound paclitaxel at a dosage of 100 mg/kg on d1 and d8, along with cisplatin 80 mg/m\u003csup\u003e2\u003c/sup\u003e or carboplatin 400 mg delivered intraperitoneally on d1. The regimen is repeated every three weeks, totaling six cycles, and at least the treatment for the first cycle must be completed. The treatment cohort comprised 56 patients, including 42 with adverse events, and doctor-patient satisfaction scores were recorded.\u003c/p\u003e\n\u003cp\u003eThe primary endpoints were success rate and adverse events. Secondary observation indicators included the effectiveness of port placement with systemic treatment and doctor-patient satisfaction. The study was performed in accordance with the guidelines of RECIST standard version 1.1 [3].\u003c/p\u003e\n\u003ch2\u003e\u003cem\u003e2.3. Key technical steps\u003c/em\u003e\u003c/h2\u003e\n\u003cp\u003eThe primary technical steps of the procedure were as follows: 1) paracentesis to establish artificial ascites, 2) implantation of an intravenous infusion port within the abdominal wall, and 3) peritoneal perfusion chemotherapy. The abdominal wall implantation of the first intravenous infusion port could be completed concurrently with the surgical intervention, but was limited to simple infusions of low-irritation chemotherapy drugs, such as cisplatin. In cases where the perfusion drugs adversely affected healing of the abdominal wall wound, delaying perfusion therapy until the day after the operation was recommended. During periodic perfusion therapy, normal saline was infused in volumes up to 1500 mL both prior to and after drug administration, serving to establish artificial ascites and promote intraperitoneal diffusion and metabolic absorption of the drug. Following the completion of perfusion, the port body and abdominal wall tubes were blocked with heparin sodium.\u003c/p\u003e\n\u003ch2\u003e\u003cem\u003e2.4. Postoperative care and treatment of complications\u003c/em\u003e\u003c/h2\u003e\n\u003cp\u003eA specialized registry was issued after surgery to record the time and disease status associated with patient port placement, alongside detailed nursing operations. The registry additionally facilitated the conduction of satisfaction surveys and follow-up communication via telephone for first-time users. The duration of care and treatment of the port during perfusion chemotherapy were clearly outlined. In instances where the port was retained after periodic perfusion, it was recommended that the ordinary intravenous infusion port be maintained at least once a month and the high pressure-resistant intravenous infusion port maintained at least once every 3 months. In the event of serious complications, such as postoperative infection, intestinal obstruction, or abdominal wall implant transfer, the intravenous infusion port device was removed. In case of intravenous infusion port joint displacement or port body interface detachment, attempts were made to adjust or reconnect the device if anatomically feasible.\u003c/p\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e3.1. Case statistics\u003c/h2\u003e \u003cp\u003eA total of 42 patients were recruited for this study. The baseline characteristics, treatment status, and doctor-patient satisfaction statistics are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, highlighting a port placement success rate of 100%. The overall treatment response rate, including complete response (CR), partial response (PR) and stable disease (SD), was 85.7%. The average operative time for the first port placement procedure was 67 minutes. Each session of periodic intraperitoneal chemotherapy was completed by the healthcare provider in less than 15 minutes. After placement of the port, the patients were capable of self-care. The average duration of port dwell time was 8.9 months.\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\u003eInformation statistics regarding IP treatment in our study sample of 42 ovarian cancer patients\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\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=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProject\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNumber of cases\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePercentage (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTNM\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eⅢc\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eⅣ\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNumber of successful catheters\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNumber of lines of treatment\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFirst-line (first treatment after relapse and metastasis)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e64.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSecond-line (2 treatments after the first\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003etreatment failure)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eThird-line and above (2 or more regimens\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003ehave been performed)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCompletion cycle\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e1 Cycle\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e4 Cycle\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e6 Cycle\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e88.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eInfusion of drugs\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCisplatin\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e90.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCarboplatin\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEvaluation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCR\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePR\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSD\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePD\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWithdraw from\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSatisfaction score (100 points)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMedical satisfaction\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e92.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePatient satisfaction\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e91.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e3.2. Adverse events\u003c/h2\u003e \u003cp\u003eThe following adverse events were recorded: (1) pain at the puncture site with an incidence rate of 40/42 (95.2%), Grade CTCAE1, which self-remitted within two days post-surgery; (2) abdominal distension with an incidence rate of 18/42 (42.9%), Grade CTCAE1, which resolved spontaneously from 5 to 7 days after surgery; (3) abdominal pain with an incidence rate of 7/42 (16.7%), Grade CTCAE1, which resolved spontaneously after 5 days (to rule out the possibility of intestinal obstruction, all patients underwent additional abdominal vertical position X-ray examinations); (4), fever with an incidence rate of 4/42 (9.5%), Grade CTCAE2, which was relieved through self-administration of ibuprofen; (5), infection with an incidence rate of 1/42 (2.4%), Grade CTCAE3. In this case, the patient underwent multi-cycle treatment and had received five sessions of traditional peritoneal puncture perfusion therapy before enrollment, with a traditional abdominal indwelling tube in place for more than one month. Considering the infection risks due to repeated abdominal punctures and the presence of a long-term external indwelling catheter, the intravenous infusion port device was removed, and systemic anti-infection treatment was initiated, following which the patient was discharged after recovery. (6) Lumen blockage was an adverse event in 6/42 patients (14.3%), Grade CTCAE1, which returned to normal after flushing the tube with heparin sodium. (7) Port body displacement was reported in 1/42 patients (2.4%). The patient completed six cycles of perfusion treatment, after which the infusion port was removed (details in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThe increasing focus on the application of hyperthermic intraperitoneal chemotherapy (HIPEC) is reflected by the findings of Wu et al. [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] and Neveu et al. [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e], which clearly demonstrate potential benefits in the management of ovarian cancer. While thermal perfusion chemotherapy is recognized as an effective option for the treatment of peritoneal malignancies, not all medical units are equipped with well-established thermal perfusion capabilities. In many primary medical units, traditional single-point peritoneal paracentesis and perfusion chemotherapy continue to be widely employed due to their low cost and ease of use, allowing for rapid catheter insertion. However, the risk of intestinal perforation associated with traditional single-point puncture poses a significant challenge. Due to the repeated, blind puncturing required for traditional single-point paracentesis, this approach increases the workload and operational risk for physicians, which is unfavorable for patients requiring repeated perfusion as part of a periodic treatment regimen. Additionally, long-term retention of catheters escalates the risk of abdominal infections. To address these limitations, we incorporated intravenous infusion port technology into the traditional peritoneal perfusion treatment protocol. The catheter tip was placed within the peritoneal cavity, while the port body was implanted subcutaneously in the abdominal wall, creating a closed, extracorporeal perfusion pathway that facilitated repeated peritoneal perfusion treatments. Furthermore, the peritoneal reabsorptive function, drug metabolism, and artificial ascites facilitated the cycle of repeated peritoneal perfusion therapy.\u003c/p\u003e \u003cp\u003eOngoing research and development are directed towards improving IP chemotherapy devices and methods. According to data obtained by the group of Padmakumar et al. [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e], treatment toxicity, patient inconvenience, and additional costs associated with the use of IP chemotherapy vary considerably across institutions. The lack of a robust and clinically feasible intra-abdominal delivery system hinders the effective transport of chemotherapy drugs into the abdominal cavity of patients with ovarian cancer, leading to underutilization of IP chemotherapy. The development of a non-ductal IP drug delivery system that preserves peritoneal drug levels while reducing systemic levels could offer a significant survival advantage as a treatment strategy that improves patient compliance. Chambers et al. [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] demonstrated that surgical peritoneal port complications accounted for 20.8% of the cases in which intraperitoneal perfusion therapy was not utilized. Previous studies by Buckingham et al. [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] and Bakrin and Gladieff [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] showed that commonly used peritoneal chemotherapy devices, as well as different placement materials, techniques, and device structures have their own distinct advantages and disadvantages. Catheter placement can be performed either during or after surgery. However, there are specific requirements regarding the placement method, timing, and site, potentially curtailing the application of IP chemotherapy extent. Catheterization techniques present various inherent limitations, including specific requirements for the placement method, timing, and site, which may restrict the use of IP chemotherapy to some extent. Clinical considerations should encompass the cost of catheters and the management of associated complications. As a result, the promotion and widespread application of many port devices and technologies at the grassroots level face significant restrictions.\u003c/p\u003e \u003cp\u003eThe subcutaneous implantation of an intravenous infusion port offers a promising alternative. This method is particularly compatible with the characteristics of intermittent abdominal perfusion therapy, effectively overcoming the limitations of traditional single-point abdominal puncture, which fails to maintain long-term drug retention. Furthermore, it avoids the disadvantages of open abdominal catheterization, such as increased trauma and procedural complexity. This technique is associated with a high success rate, fewer complications, and simplified procedures for healthcare providers, additionally reducing the risk of patient infection and facilitating easier device removal. Such improvements in the method promote the utilization of IP treatment for advanced ovarian cancer and facilitate its implementation in primary medical facilities.\u003c/p\u003e \u003cp\u003eThere are two opposing viewpoints to IP chemotherapy. Wang et al. [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] argued that IP combined with intravenous chemotherapy requires substantially more time as well as human and material resources than intravenous administration alone. The group additionally highlighted the potential for increased chemotherapy-related toxicity and complications linked to catheter placement and drug perfusion. On the other hand, Yeku and co-workers [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] maintain that these challenges can be overcome, asserting that IP therapy ultimately offers significant benefits.\u003c/p\u003e \u003cp\u003eDuring the course of technical development, we selected a high-resistance, triple-chamber valve reflux device to reduce the risk of intravenous infusion port occlusion caused by ascites crystallization, chemotherapeutic drug deposition, and intra-abdominal fibrin sheath formation. Studies by the research teams of Manning-Geist et al. [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] and Fayzullin et al. [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] have highlighted common complications linked to infusion ports, including displacement, catheter distortion or damage, tube blockage, thrombosis, and infection. We observed similar complications in the application of this technology, such as lumen blockage (6/42, 14.3%) and port body displacement (1/42, 2.4%). Due to the focus on details such as the subcutaneous catheter position and port connection, and the fact that these procedures are carried out under the assistance of technically proficient medical staff, the incidence of other catheter-related complications has been effectively reduced. The single case of abdominal infection was linked to high risk factors in the patient\u0026rsquo;s retrospective medical history, indicating the necessity for comprehensive evaluation of abdominal status for patients undergoing repeated peritoneal punctures and external abdominal catheterization before the application of this technique, which can effectively reduce the likelihood of abdominal infection. This investigation was initiated in February 2019 and continued for over 5 years at the time of data analysis. Throughout this period, there were no cases of complete tube blockage that led to treatment interruption. The average retention time for enrolled patients exceeded 7 months, which fully met the needs of periodic peritoneal perfusion treatment in internal medicine.\u003c/p\u003e \u003cp\u003eIn addition to catheter complications, we observed gastrointestinal reactions, myelosuppression, and other chemotherapy-related adverse events, but these were not classified as technical complications. To date, no randomized trials have established the equivalence of intraperitoneal carboplatin administration to that of intraperitoneal cisplatin in terms of survival impact. Cadoo et al. [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] reported that cisplatin infusion chemotherapy is considered effective with a low incidence of adverse reactions. However, other researchers, such as the group of Hasegawa et al. [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], favor the use of carboplatin, based on studies suggesting that intraperitoneal carboplatin may be equally effective as cisplatin. Consequently, the platinum drugs for intraperitoneal perfusion were not strictly defined in this study. Due to the limited sample size, differences in postoperative adverse effects resulting from cisplatin and carboplatin could not be evaluated.\u003c/p\u003e \u003cp\u003eThe present study has a number of limitations that should be acknowledged. The observation period is short, which could lead to the overlooking of certain complications that were not statistically observed, such as catheter shedding and port body turnover. Additionally, complication data may be subject to bias and errors due to the small sample size. This study is a single-arm experiment, lacking a set control group, which may limit evaluation of the authenticity and reliability of the intervention effect. The current intravenous infusion port device is more expensive than the traditional single-point abdominal puncture, necessitating the careful selection of appropriate patients. Furthermore, the procedure requires a physician with substantial experience in peritoneal puncture to avoid potential complications. A skilled team is essential for the effective and safe implementation of the intravenous infusion port technology. Therefore, it is crucial to not only identify the patient population suitable for intraperitoneal chemotherapy but also devise personalized care strategies to enhance their quality of life [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eAcknowledgments\u003c/p\u003e\n\u003cp\u003eThe authors thank Dr. Gang Xu for his excellent technical assistance and International Science Editing ( http://www.internationalscienceediting.com ) for editing this manuscript.\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eThis study was supported by four funding grants: Central University Basic Research Fund of China (xzy012021061), Xi\u0026apos;an Jiaotong University, 2024 Undergraduate Education Reform Research Project (24ZK29Y)，Natural Science Foundation of Shaanxi Province (2020 JQ-517), and General Project of Clinical Research of The First Affiliated Hospital of Xi\u0026apos;an Jiaotong University (XJT U1AF-CRF-2017-022).\u003c/p\u003e\n\u003cp\u003eAuthor information\u003c/p\u003e\n\u003cp\u003eAuthor notes\u003c/p\u003e\n\u003cp\u003eSirui Hu and Jingyi Zhang\u0026nbsp;have contributed equally to this work.\u003c/p\u003e\n\u003cp\u003eAuthors and Affiliations\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDepartment of Medical Oncology, The First Affiliated Hospital of Xi\u0026rsquo;an Jiaotong University, Xi\u0026rsquo;an, Shaanxi,\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ePR China\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSirui Hu, Jingyi Zhang, Lingxiao Zhang, Jiao Yang, Xiaoai Zhang, Jin Yang and Danfeng Dong, Le Wang\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDepartment of General Surgery, HeYang Hospital of Traditional Chinese Medicine, Weinan, Shaanxi,\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ePR China\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLiang Zhao\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePhysical Medicine and Rehabilitation, Honghui Hospital Affiliated to Xi\u003c/strong\u003e\u003cstrong\u003e\u0026rsquo;\u003c/strong\u003e\u003cstrong\u003ean Jiaotong University, Xi\u0026rsquo;an, Shaanxi,\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ePR China\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLina Wang\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eContributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSirui Hu, Jingyi Zhang and Le Wang wrote the manuscript. Lingxiao Zhang, and Jiao Yang analyzed the data. Liang Zhao and Lina Wang performed data acquisition and curation. Le Wang, Xiaoai Zhang, Jin Yang and Danfeng Dong conceptualized the idea and designed the research. All authors interpreted the data, critically reviewed the manuscript, had the opportunity to make revisions and approved the final version for submission.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCorresponding authors\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCorrespondence to Le Wang.\u003c/p\u003e\n\u003cp\u003eEthics declarations\u003c/p\u003e\n\u003cp\u003eConflict of interests\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests. The authors informed consent was obtained from all individual participants included in the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEthical approval\u003c/p\u003e\n\u003cp\u003eClinical trial number: Not applicable.This study was a retrospective evaluation of a new medical technology implementation and did not constitute a clinical trial. The abdominal wall implantation technique for intraperitoneal chemotherapy delivery was approved as a new medical technology project by the First Affiliated Hospital of Xi\u0026apos;an Jiaotong University (Approval No. XJYFY-2018-N5) in October 2018. The Ethics Committee of the same institution reviewed and approved both the technical protocol and patient informed consent documents.\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Ethics Committee of the First Affiliated Hospital of Xi\u0026rsquo;an Jiaotong University (XJTU1AF2020LSK-087).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from all individual participants included in the study.All participants provided consent for the publication of anonymized data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRights and permissions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOpen Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article\u0026apos;s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article\u0026apos;s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eA. Ogasawara, H. Matsushita, T.Z. Tan, D. Shintani, J. Ye, S. Nagao, et al. Immunological impact of intraperitoneal and intravenous chemotherapy in ovarian cancer, translational analyses of the phase 3 iPocc trial. Gynecol. Oncol. 191 (2024) 124\u0026ndash;131.\u003c/li\u003e\n \u003cli\u003eQ. Tang, M. Huang, J. Zhang, Z. Huang, L. Wang, Z. Gong, et al. Comparative survival outcomes of hyperthermic intraperitoneal chemotherapy, intraperitoneal chemotherapy and intravenous chemotherapy for primary advanced ovarian cancer: a network meta-analysis. J. Clin. Med. 12 (3) (2023) 1111.\u003c/li\u003e\n \u003cli\u003eL.H. Schwartz, S. Liti\u0026egrave;re, E. de Vries, R. Ford, S. Gwyther, S. Mandrekar, et al. RECIST 1.1-Update and clarification: from the RECIST committee. Eur. J. Cancer. 62 (2016) 132\u0026ndash;137.\u003c/li\u003e\n \u003cli\u003eM.F. Wu, L.J. Wang, Y.F. Ye, C.H. Liu, H.W. Lu, T.T. Yao, et al. Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial. BMJ Open. 11 (12) (2021) e046415.\u003c/li\u003e\n \u003cli\u003eJ. Neveu, E. Tremblay, F. Mercier, S. Garneau, B. Cormier. Developing a hyperthermic intraperitoneal chemotherapy (HIPEC) gynecologic oncology program: a Canadian experience. Int. J. Gynecol. Cancer 33 (12) (2023) 1957\u0026ndash;1965.\u003c/li\u003e\n \u003cli\u003eS. Padmakumar, N. Parayath, F. Leslie, S.V. Nair, D. Menon, M.M. Amiji. Intraperitoneal chemotherapy for ovarian cancer using sustained-release implantable devices. Expert. Opin. Drug. Deliv. 15 (5) (2018) 481\u0026ndash;494.\u003c/li\u003e\n \u003cli\u003eL.M. Chambers, J. Son, M. Radeva, R. DeBernardo. Evaluation of non-completion of intraperitoneal chemotherapy in patients with advanced epithelial ovarian cancer. J. Gynecol. Oncol. 30 (6) (2019) e93.\u003c/li\u003e\n \u003cli\u003eL. Buckingham, A. Koenig, E.M. Ko, C.M. Brensinger, N. Latif, C. Hummel, et al. Low rate of intraperitoneal port placement in ovarian cancer patients, a population-based assessment. Int. J. Gynecol. Cancer 29 (7) (2019) 1177\u0026ndash;1181.\u003c/li\u003e\n \u003cli\u003eN. Bakrin, L. Gladieff. Malignant epithelial ovarian cancer: Role of intra peritoneal chemotherapy and hyperthermic intra peritoneal chemotherapy (HIPEC): Article drafted from the French Guidelines in oncology entitled \u0026quot;Initial management of patients with epithelial ovarian cancer\u0026quot; developed by FRANCOGYN, CNGOF, SFOG, GINECO-ARCAGY under the aegis of CNGOF and endorsed by INCa. Gynecol. Obstet. Fertil. Senol. 47 (2) (2019) 214\u0026ndash;221.\u003c/li\u003e\n \u003cli\u003eJ.Y. Wang, M. Gross, R.R. Urban, S. Jorge. Intraperitoneal and hyperthermic intraperitoneal chemotherapy for the treatment of ovarian cancer. Curr. Treat. Options Oncol. 25 (3) (2024) 313\u0026ndash;329.\u003c/li\u003e\n \u003cli\u003eO.O. Yeku. Intraperitoneal therapy for ovarian cancer \u0026ndash; some answers, more questions, and missed opportunities. NEJM Evid. 2 (5) (2023) EVIDe2300048.\u003c/li\u003e\n \u003cli\u003eB.L. Manning-Geist, M.W. Sullivan, V. Sarda, A.A. Gockley, M.G. Del Carmen, U. Matulonis, et al. Disease distribution at presentation impacts benefit of IP chemotherapy among patients with advanced-stage ovarian cancer. Ann. Surg. Oncol. 28 (11) (2021) 6705\u0026ndash;6713.\u003c/li\u003e\n \u003cli\u003eA. Fayzullin, A. Bakulina, K. Mikaelyan, A. Shekhter, A. Guller. Implantable drug delivery systems and foreign body reaction: traversing the current clinical landscape. Bioengineering (Basel) 8 (12) 2021 205.\u003c/li\u003e\n \u003cli\u003eK.A. Cadoo, R.N. Grisham, R.E. O\u0026apos;Cearbhaill, N.N. Boucicaut, M. Henson, A. Iasonos, et al. A phase 1 dose-escalation study of intraperitoneal cisplatin, intravenous/intraperitoneal paclitaxel, bevacizumab, and olaparib for newly diagnosed ovarian cancer. Gynecol. Oncol. 157 (1) (2020) 214\u0026ndash;221.\u003c/li\u003e\n \u003cli\u003eK. Hasegawa, M. Shimada, S. Takeuchi, H. Fujiwara, Y. Imai, N. Iwasa, et al. A phase 2 study of intraperitoneal carboplatin plus intravenous dose-dense paclitaxel in front-line treatment of suboptimal residual ovarian cancer. Br. J. Cancer 122 (6) (2020) 766\u0026ndash;770.\u003c/li\u003e\n \u003cli\u003eL. Foster, C. Girgis, A. Kirby, P. Harnett, A. Brand. The use of intraperitoneal chemotherapy for advanced ovarian cancer \u0026ndash; The experience of a tertiary referral centre. Aust. N Z J Obstet. Gynaecol. 64 (3) (2024) 239\u0026ndash;244.\u003c/li\u003e\n\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":"Infusion port, Abdominal wall implantation, Ovarian cancer, Intraperitoneal perfusion chemotherapy","lastPublishedDoi":"10.21203/rs.3.rs-6642224/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6642224/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThis study evaluated the safety and efficacy of a novel intravenous infusion port abdominal wall implantation technique for intraperitoneal chemotherapy in advanced-stage ovarian cancer (FIGO III-IV). In a single-arm clinical trial of 42 patients, the implantation success rate reached 100%, with 97.6% of patients completing at least four treatment cycles. The overall response rate (CR+PR) was 69.0%. Common complications included puncture site pain (95.2%), abdominal distension (42.9%), and lumen blockage (14.3%), all of which were mild and manageable. Both physician and patient satisfaction scores exceeded 91 points. The technique eliminated the need for laparotomy, minimized trauma, simplified procedures, and ensured long-term safety, making it particularly suitable for peritoneal metastasis and pelvic recurrence. Limitations included the small sample size and lack of a control group, warranting future multicenter validation. This approach provides a feasible option for intraperitoneal chemotherapy in primary care settings, potentially optimizing treatment strategies for advanced ovarian cancer.\u003c/p\u003e","manuscriptTitle":"Evaluation of Intravenous Infusion Port Abdominal Wall Implantation Technology for Delivery of Intraperitoneal Chemotherapy in Advanced-Stage Ovarian Cancer","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-24 06:10:33","doi":"10.21203/rs.3.rs-6642224/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":"35bb6508-9295-4ae2-9d40-2d5295ffaf88","owner":[],"postedDate":"June 24th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-09-10T06:38:48+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-24 06:10:33","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6642224","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6642224","identity":"rs-6642224","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}