{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T11:47:36Z","timestamp":1772538456252,"version":"3.50.1"},"reference-count":36,"publisher":"MDPI AG","issue":"20","license":[{"start":{"date-parts":[[2023,10,14]],"date-time":"2023-10-14T00:00:00Z","timestamp":1697241600000},"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>Background and aims: In the treatment of post-cholecystectomy bile leaks, endoscopic naso-biliary drainage (ENBD) or biliary stenting using plastic stents is the standard of care. Fully covered self-expandable metal stent (FCSEMS) placement across the sphincter of Oddi is considered a salvage therapy for refractory cases, but pancreatitis and migration are the major concerns. Intraductal placement of a dumbbell-shaped FCSEMS (D-SEMS) could avoid these drawbacks of FCMSESs. In this retrospective study, we investigated the usefulness of intraductal placement of the D-SEMS for post-cholecystectomy bile leaks. Methods: Six patients who underwent intraductal placement of the D-SEMS for post-cholecystectomy bile leaks were enrolled. This method was performed as initial treatment in three patients and as salvage treatment in three ENBD refractory cases. Results: Technical and clinical successes were obtained in 6 (100%) patients and 5 (83%) patients, respectively. One clinically unsuccessful patient required laparoscopic peritoneal lavage. The early adverse event was one case of mild pancreatitis (17%). The median duration of the D-SEMS indwelling was 61 days (42\u2013606 days) with no migration cases, all of which were successfully removed. The median follow-up after index ERCP was 761 (range: 161\u20131392) days with no cases of recurrent bile leaks. Conclusions: Intraductal placement of the D-SEMS for post-cholecystectomy bile leaks might be safe and effective even in refractory cases.<\/jats:p>","DOI":"10.3390\/jcm12206530","type":"journal-article","created":{"date-parts":[[2023,10,14]],"date-time":"2023-10-14T14:59:59Z","timestamp":1697295599000},"page":"6530","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Usefulness of Intraductal Placement of a Dumbbell-Shaped Fully Covered Self-Expandable Metal Stent for Post-Cholecystectomy Bile Leaks"],"prefix":"10.3390","volume":"12","author":[{"given":"Keito","family":"Nakagawa","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Kumagaya General Hospital, Saitama 360-8567, Japan"},{"name":"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama 350-8550, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8182-3524","authenticated-orcid":false,"given":"Saburo","family":"Matsubara","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama 350-8550, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kentaro","family":"Suda","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama 350-8550, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama 350-8550, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masashi","family":"Oka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama 350-8550, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sumiko","family":"Nagoshi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama 350-8550, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,10,14]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"674","DOI":"10.1097\/MCG.0000000000000044","article-title":"Endoscopic management of biliary leaks after laparoscopic cholecystectomy","volume":"48","author":"Rustagi","year":"2014","journal-title":"J. Clin. Gastroenterol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1016\/j.jamcollsurg.2010.06.013","article-title":"Is there a role for endoscopic therapy as a definitive treatment for post-laparoscopic bile duct injuries?","volume":"211","author":"Fatima","year":"2010","journal-title":"J. Am. Coll. Surg."},{"key":"ref_3","first-page":"1496","article-title":"Sphincterotomy in the treatment of biliary leakage","volume":"49","author":"Llach","year":"2002","journal-title":"Hepatogastroenterology"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"567","DOI":"10.1016\/S0016-5107(04)01892-9","article-title":"Endoscopic therapy for bile leak based on a new classification: Results in 207 patients","volume":"60","author":"Sandha","year":"2004","journal-title":"Gastrointest. Endosc."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1007\/s004649900663","article-title":"Biliary stenting is more effective than sphincterotomy in the resolution of biliary leaks","volume":"12","author":"Marks","year":"1998","journal-title":"Surg. Endosc."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1069","DOI":"10.1016\/j.gie.2007.02.022","article-title":"Endoscopic treatment of bile leaks: Current standards and recent innovations","volume":"65","author":"Shah","year":"2007","journal-title":"Gastrointest. Endosc."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1111\/j.1443-1661.2009.00878.x","article-title":"Endoscopic sphincterotomy alone in the management of low-grade biliary leaks due to cholecystectomy","volume":"21","author":"Aksoz","year":"2009","journal-title":"Dig. Endosc."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"405","DOI":"10.1097\/00042737-200604000-00014","article-title":"Biliary stenting alone versus biliary stenting plus sphincterotomy for the treatment of post-laparoscopic cholecystectomy biliary leaks: A prospective randomized study","volume":"18","author":"Mavrogiannis","year":"2006","journal-title":"Eur. J. Gastroenterol. Hepatol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1007\/s00464-007-9381-y","article-title":"A comparative study of 10-Fr vs. 7-Fr straight plastic stents in the treatment of postcholecystectomy bile leak","volume":"22","author":"Katsinelos","year":"2008","journal-title":"Surg. Endosc."},{"key":"ref_10","first-page":"409","article-title":"Endoscopic management of postcholecystectomy biliary leakage","volume":"9","author":"Singh","year":"2010","journal-title":"Hepatobiliary Pancreat. Dis. Int."},{"key":"ref_11","first-page":"200","article-title":"Eleven-year experience on the endoscopic treatment of post-cholecystectomy bile leaks","volume":"24","author":"Fasoulas","year":"2011","journal-title":"Ann. Gastroenterol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"248","DOI":"10.5946\/ce.2014.47.3.248","article-title":"Endoscopic management of bile leakage after cholecystectomy: A single-center experience for 12 years","volume":"47","author":"Kim","year":"2014","journal-title":"Clin. Endosc."},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Canena, J., Horta, D., Coimbra, J., Meireles, L., Russo, P., Marques, I., Ricardo, L., Rodrigues, C., Capela, T., and Carvalho, D. (2015). Outcomes of endoscopic management of primary and refractory postcholecystectomy biliary leaks in a multicentre review of 178 patients. BMC Gastroenterol., 15.","DOI":"10.1186\/s12876-015-0334-y"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"E1895","DOI":"10.1055\/a-1300-1319","article-title":"Endoscopic plastic stent therapy for bile leaks following total vs subtotal cholecystectomy","volume":"8","author":"Yachimski","year":"2020","journal-title":"Endosc. Int. Open"},{"key":"ref_15","first-page":"904","article-title":"Efficacy and safety of endoscopic retrograde cholangiopancreatography with endoscopic sphincterotomy and biliary stenting in post-operative bile leaks","volume":"29","author":"Celik","year":"2023","journal-title":"Ulus. Travma Acil Cerrahi Derg."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1055","DOI":"10.1007\/s11605-019-04143-x","article-title":"Endoscopic Management of Acute Biliopancreatic Disorders","volume":"23","author":"Juza","year":"2019","journal-title":"J. Gastrointest. Surg."},{"key":"ref_17","first-page":"E91","article-title":"Management of post-cholecystectomy biliary fistula according to type of cholecystectomy","volume":"3","author":"Sultan","year":"2015","journal-title":"Endosc. Int. Open"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"547","DOI":"10.4253\/wjge.v7.i5.547","article-title":"Biliary leakage after urgent cholecystectomy: Optimization of endoscopic treatment","volume":"7","author":"Ljubicic","year":"2015","journal-title":"World J. Gastrointest. Endosc."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.gie.2006.07.036","article-title":"Temporary placement of covered self-expandable metallic stents in patients with biliary leak: Midterm evaluation of a pilot study","volume":"66","author":"Kahaleh","year":"2007","journal-title":"Gastrointest. Endosc."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"781","DOI":"10.1055\/s-0029-1215050","article-title":"Fully covered self-expandable metallic stents in the management of complex biliary leaks: Preliminary data\u2014A case series","volume":"41","author":"Wang","year":"2009","journal-title":"Endoscopy"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1097\/MOG.0b013e3283438a26","article-title":"Covered self-expandable metal stents for benign biliary tract diseases","volume":"27","author":"Baron","year":"2011","journal-title":"Curr. Opin. Gastroenterol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"96","DOI":"10.5009\/gnl.2011.5.1.96","article-title":"Temporary placement of a newly designed, fully covered, self-expandable metal stent for refractory bile leaks","volume":"5","author":"Hwang","year":"2011","journal-title":"Gut Liver"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1016\/j.gie.2012.02.034","article-title":"Use of covered self-expandable metal stents for endoscopic management of benign biliary disease not related to stricture (with video)","volume":"76","author":"Akbar","year":"2012","journal-title":"Gastrointest. Endosc."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1016\/j.gie.2014.11.038","article-title":"A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos)","volume":"82","author":"Canena","year":"2015","journal-title":"Gastrointest. Endosc."},{"key":"ref_25","first-page":"315","article-title":"Endoscopic treatment of nonstricture-related benign biliary diseases using covered self-expandable metal stents","volume":"47","author":"Irani","year":"2015","journal-title":"Endoscopy"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1080","DOI":"10.1016\/j.gie.2012.01.016","article-title":"Feasibility of placing a modified fully covered self-expandable metal stent above the papilla to minimize stent-induced bile duct injury in patients with refractory benign biliary strictures (with videos)","volume":"75","author":"Moon","year":"2012","journal-title":"Gastrointest. Endosc."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"680","DOI":"10.1016\/j.surg.2010.12.002","article-title":"Bile leakage after hepatobiliary and pancreatic surgery: A definition and grading of severity by the International Study Group of Liver Surgery","volume":"149","author":"Koch","year":"2011","journal-title":"Surgery"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"446","DOI":"10.1016\/j.gie.2009.10.027","article-title":"A lexicon for endoscopic adverse events: Report of an ASGE workshop","volume":"71","author":"Cotton","year":"2010","journal-title":"Gastrointest. Endosc."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"6357","DOI":"10.3748\/wjg.v27.i38.6357","article-title":"Fully covered metal biliary stents: A review of the literature","volume":"27","author":"Lam","year":"2021","journal-title":"World J. Gastroenterol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"1074","DOI":"10.1055\/a-0835-5940","article-title":"Endoscopic management of biliary leaks: A systematic review with meta-analysis","volume":"51","author":"Vlaemynck","year":"2019","journal-title":"Endoscopy"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"152","DOI":"10.1007\/s10620-013-2859-7","article-title":"Endoscopic treatment of benign biliary strictures using covered self-expandable metal stents (CSEMS)","volume":"59","author":"Irani","year":"2014","journal-title":"Dig. Dis. Sci."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"771","DOI":"10.1007\/s00464-011-1950-4","article-title":"Risk factors for pancreatitis following transpapillary self-expandable metal stent placement","volume":"26","author":"Kawakubo","year":"2012","journal-title":"Surg. Endosc."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"E1603","DOI":"10.1055\/a-1244-1989","article-title":"Novel risk factors for recurrent biliary obstruction and pancreatitis after metallic stent placement in pancreatic cancer","volume":"8","author":"Takeda","year":"2020","journal-title":"Endosc. Int. Open"},{"key":"ref_34","doi-asserted-by":"crossref","unstructured":"Fukuda, K., Nakai, Y., Mizuno, S., Sato, T., Noguchi, K., Kanai, S., Suzuki, T., Hakuta, R., Ishigaki, K., and Saito, K. (2022). Endoscopic Bridge-and-Seal of Bile Leaks Using a Fully Covered Self-Expandable Metallic Stent above the Papilla. J. Clin. Med., 11.","DOI":"10.3390\/jcm11206019"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"474","DOI":"10.1007\/s10620-017-4768-7","article-title":"Endoscopic Therapy of Biliary Injury After Cholecystectomy","volume":"63","author":"Rainio","year":"2018","journal-title":"Dig. Dis. Sci."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"e281","DOI":"10.1002\/deo2.281","article-title":"Efficacy and associated factors of endoscopic transpapillary drainage for postoperative biliary leakage","volume":"4","author":"Murata","year":"2024","journal-title":"DEN Open"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/20\/6530\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:07:01Z","timestamp":1760130421000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/20\/6530"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,14]]},"references-count":36,"journal-issue":{"issue":"20","published-online":{"date-parts":[[2023,10]]}},"alternative-id":["jcm12206530"],"URL":"https:\/\/doi.org\/10.3390\/jcm12206530","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10,14]]}}}