{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T18:51:15Z","timestamp":1793731875650,"version":"4.6.1"},"reference-count":19,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2025,1,24]],"date-time":"2025-01-24T00:00:00Z","timestamp":1737676800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Objectives: In hepatopancreatic diseases, stenting is widely employed to manage cholangitis and obstructive jaundice. Stent materials are primarily categorized as plastic or metal. Plastic stents have notable advantages, such as reduced likelihood of peripheral bile duct obstruction, a lower cost, and the ease of replacement compared to metallic stents. However, their patency period is shorter due to narrower diameters. Plastic stents are typically composed of materials like polyurethane or polyethylene. To improve patency, new dual-layer stents combine polyurethane with polytetrafluoroethylene (PTFE). PTFE, used in the inner layer, is expected to prevent biofilm formation. This study aimed to assess the clinical efficacy of this dual-layer stent. Methods: A retrospective analysis was performed on 48 cases (Group R) using REGULUS\u00ae from November 2022 to November 2023 and 30 cases (Group IS) using inside-type plastic stents from January 2020 to November 2023 for malignant hilar and intrahepatic bile duct obstructions. Stent patency and clinical outcomes were compared between the groups. Results: There was no significant difference in the recurrent biliary obstruction (RBO) rate between the groups (p = 0.644). The time to recurrent biliary obstruction (TRBO) was 74 days in Group R and 118 days in Group IS, with no significant difference (p = 0.219). Conclusions: The dual-layer stent placed across the papilla demonstrated comparable clinical outcomes to inside-type stents. The PTFE inner layer likely reduces biofilm formation, enhancing patency. Across-the-papilla placement may facilitate reinterventions in challenging cases, broadening stent options.<\/jats:p>","DOI":"10.3390\/jcm14030764","type":"journal-article","created":{"date-parts":[[2025,1,24]],"date-time":"2025-01-24T08:48:23Z","timestamp":1737708503000},"page":"764","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy of a Novel Dual-Layer Plastic Stents for Malignant Biliary Obstruction"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8417-8804","authenticated-orcid":false,"given":"Masanari","family":"Sekine","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Ijima","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Ota Memorial Hospital, Gunma 373-8585, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoaki","family":"Noguchi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Ota Memorial Hospital, Gunma 373-8585, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eishin","family":"Kurihara","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Ota Memorial Hospital, Gunma 373-8585, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsutomu","family":"Kobatake","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Ota Memorial Hospital, Gunma 373-8585, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taku","family":"Mizutani","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryo","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayoko","family":"Aoyama","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Goya","family":"Sasaki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azumi","family":"Sato","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shu","family":"Kojima","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8448-9576","authenticated-orcid":false,"given":"Hirosato","family":"Mashima","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,1,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Wiggers, J.K., Coelen, R.J., Rauws, E.A., van Delden, O.M., van Eijck, C.H., de Jonge, J., Porte, R.J., Buis, C.I., Dejong, C.H., and Molenaar, I.Q. (2015). Preoperative endoscopic versus percutaneous transhepatic biliary drainage in potentially resectable perihilar cholangiocarcinoma (DRAINAGE trial): Design and rationale of a randomized controlled trial. BMC Gastroenterol., 15.","DOI":"10.1186\/s12876-015-0251-0"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1007\/s00535-010-0298-1","article-title":"Endoscopic nasobiliary drainage is the most suitable preoperative biliary drainage method in the management of patients with hilar cholangiocarcinoma","volume":"46","author":"Kawakami","year":"2011","journal-title":"J. Gastroenterol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1146","DOI":"10.1111\/jgh.14050","article-title":"Multicenter study of endoscopic preoperative biliary drainage for malignant hilar biliary obstruction: E-POD hilar study","volume":"33","author":"Nakai","year":"2018","journal-title":"J. Gastroenterol. Hepatol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1002\/jhbp.870","article-title":"Clinical practice guidelines for the management of biliary tract cancers 2019: The 3rd English edition","volume":"28","author":"Nagino","year":"2021","journal-title":"J. Hepato-Biliary-Pancreat. Sci."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"e182","DOI":"10.1016\/j.cgh.2020.12.020","article-title":"Superiority of Self-Expandable Metallic Stents Over Plastic Stents in Treatment of Malignant Distal Biliary Strictures","volume":"20","author":"Jang","year":"2022","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"139","DOI":"10.5946\/ce.2016.024","article-title":"Mechanisms of Biliary Plastic Stent Occlusion and Efforts at Prevention","volume":"49","author":"Kwon","year":"2016","journal-title":"Clin. Endosc."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1016\/j.gie.2023.03.007","article-title":"Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: A multicenter, randomized trial","volume":"98","author":"Kanno","year":"2023","journal-title":"Gastrointest. Endosc."},{"key":"ref_8","first-page":"1153","article-title":"Evaluating optimal bilateral biliary stenting in endoscopic reintervention after initial plastic stent dysfunction for unresectable malignant hilar biliary obstruction: Retrospective cross-sectional study","volume":"36","author":"Okuno","year":"2024","journal-title":"Dig. Endosc."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"8178","DOI":"10.1007\/s00464-023-10464-5","article-title":"Meta-analysis on clinical outcomes of suprapapillary versus transpapillary stent insertion in malignant biliary obstruction","volume":"37","author":"Yang","year":"2023","journal-title":"Surg. Endosc."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1111\/den.12080","article-title":"Newly designed plastic stent for endoscopic placement above the sphincter of Oddi in patients with malignant hilar biliary obstruction","volume":"25","author":"Ishiwatari","year":"2013","journal-title":"Dig. Endosc."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"452","DOI":"10.1038\/bmt.2012.244","article-title":"Investigation of the freely available easy-to-use software \u2019EZR\u2019 for medical statistics","volume":"48","author":"Kanda","year":"2013","journal-title":"Bone Marrow Transpl."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"595","DOI":"10.4254\/wjh.v13.i5.595","article-title":"Endoscopic retrograde cholangiopancreatography drainage for palliation of malignant hilar biliary obstruction\u2014Stent-in-stent or side-by-side? A systematic review and meta-analysis","volume":"13","author":"Ribeiro","year":"2021","journal-title":"World J. Hepatol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"EVIDoa2200015","DOI":"10.1056\/EVIDoa2200015","article-title":"Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer","volume":"1","author":"Oh","year":"2022","journal-title":"NEJM Evid."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1853","DOI":"10.1016\/S0140-6736(23)00727-4","article-title":"Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): A randomised, double-blind, placebo-controlled, phase 3 trial","volume":"401","author":"Kelley","year":"2023","journal-title":"Lancet"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2869","DOI":"10.1007\/s00464-021-08576-x","article-title":"Stent placement above the sphincter of Oddi is a useful option for patients with inoperable malignant hilar biliary obstruction","volume":"36","author":"Kurita","year":"2022","journal-title":"Surg. Endosc."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Kogure, H., Kato, H., Kawakubo, K., Ishiwatari, H., Katanuma, A., Okabe, Y., Ueki, T., Ban, T., Hanada, K., and Sugimori, K. (2021). A Prospective Multicenter Study of \u201cInside Stents\u201d for Biliary Stricture: Multicenter Evolving Inside Stent Registry (MEISteR). J. Clin. Med., 10.","DOI":"10.3390\/jcm10132936"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"864","DOI":"10.1002\/jhbp.990","article-title":"Utility of the inside stent as a preoperative biliary drainage method for patients with malignant perihilar biliary stricture","volume":"28","author":"Nakamura","year":"2021","journal-title":"J. Hepatobiliary Pancreat. Sci."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1139","DOI":"10.1007\/s10620-022-07718-y","article-title":"Clinical Outcomes of Inside Stents and Conventional Plastic Stents as Bridge-to-Surgery Options for Malignant Hilar Biliary Obstruction","volume":"68","author":"Ishiwatari","year":"2023","journal-title":"Dig. Dis. Sci."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"913","DOI":"10.1136\/gut.31.8.913","article-title":"Clogging of biliary endoprostheses: A new perspective","volume":"31","author":"Coene","year":"1990","journal-title":"Gut"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/3\/764\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T10:35:35Z","timestamp":1759919735000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/3\/764"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,24]]},"references-count":19,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2025,2]]}},"alternative-id":["jcm14030764"],"URL":"https:\/\/doi.org\/10.3390\/jcm14030764","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,24]]}}}