Jan-Werner Poley1, Thierry Ponchon2, Andreas Puespoek3, Marco Bruno1, André Roy4, Joyce Peetermans5, Matthew Rousseau5, Vincent Lépilliez2, Werner Dolak6, Andrea Tringali7, Daniel Blero8, David Carr-Locke9, Guido Costamagna7, Jacques Devière8. 1. Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 2. Service d'Hépato-Gastroentérologie, Hôpital Edouard Herriot, Lyon, France. 3. Department of Medicine, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria. 4. Département de Chirurgie, Hôpital Saint-Luc, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada. 5. Boston Scientific Corporation, Marlboro, Massachusetts, USA. 6. Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Vienna, Austria. 7. Fondazione Policlinico Universitario A. Gemelli IRCCS, Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Centre for Endoscopic Research Therapeutics and Training (CERTT), Rome, Italy. 8. Department of Gastroenterology and Hepato-pancreatology, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. 9. The Center for Advanced Digestive Care, Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, New York, USA.
Abstract
BACKGROUND AND AIMS: Minimally invasive treatments of anastomotic benign biliary stricture (BBS) after orthotopic liver transplantation (OLT) include endoscopic placement of multiple plastic stents or fully covered self-expandable metal stents (FCSEMSs). No multiyear efficacy data are available on FCSEMS treatment after OLT. METHODS: We prospectively studied long-term efficacy and safety of FCSEMS treatment in adults aged ≥18 years with past OLT, cholangiographically confirmed BBS, and an indication for ERCP with stent placement. Stent removal was planned after 4 to 6 months, with subsequent follow-up until 5 years or stricture recurrence. Long-term outcomes were freedom from stricture recurrence, freedom from recurrent stent placement, and stent-related serious adverse events (SAEs). RESULTS: In 41 patients, long-term follow-up began after FCSEMS removal (n = 33) or observation of complete distal migration (CDM) (n = 8). On an intention-to-treat basis, the 5-year probability of remaining stent-free after FCSEMS removal or observation of CDM was 48.9% (95% confidence interval [CI], 33.2%-64.7%) among all patients and 60.9% (95% CI, 43.6%-78.2%) among 31 patients with over 4 months of FCSEMS indwell time. In 28 patients with stricture resolution at FCSEMS removal or observed CDM (median, 5.0 months indwell time), the 5-year probability of no stricture recurrence was 72.6% (95% CI, 55.3%-90%). Sixteen patients (39%) had at least 1 related SAE, most commonly cholangitis (n = 10). CONCLUSIONS: By 5 years after temporary FCSEMS treatment of post-OLT BBS, approximately half of all patients remained stent-free on an intention-to-treat basis. Stent-related SAEs (especially cholangitis) were common. FCSEMS placement is a viable long-term treatment option for patients with post-OLT BBS. (Clinical trial registration number: NCT01014390.).
BACKGROUND AND AIMS: Minimally invasive treatments of anastomotic benign biliary stricture (BBS) after orthotopic liver transplantation (OLT) include endoscopic placement of multiple plastic stents or fully covered self-expandable metal stents (FCSEMSs). No multiyear efficacy data are available on FCSEMS treatment after OLT. METHODS: We prospectively studied long-term efficacy and safety of FCSEMS treatment in adults aged ≥18 years with past OLT, cholangiographically confirmed BBS, and an indication for ERCP with stent placement. Stent removal was planned after 4 to 6 months, with subsequent follow-up until 5 years or stricture recurrence. Long-term outcomes were freedom from stricture recurrence, freedom from recurrent stent placement, and stent-related serious adverse events (SAEs). RESULTS: In 41 patients, long-term follow-up began after FCSEMS removal (n = 33) or observation of complete distal migration (CDM) (n = 8). On an intention-to-treat basis, the 5-year probability of remaining stent-free after FCSEMS removal or observation of CDM was 48.9% (95% confidence interval [CI], 33.2%-64.7%) among all patients and 60.9% (95% CI, 43.6%-78.2%) among 31 patients with over 4 months of FCSEMS indwell time. In 28 patients with stricture resolution at FCSEMS removal or observed CDM (median, 5.0 months indwell time), the 5-year probability of no stricture recurrence was 72.6% (95% CI, 55.3%-90%). Sixteen patients (39%) had at least 1 related SAE, most commonly cholangitis (n = 10). CONCLUSIONS: By 5 years after temporary FCSEMS treatment of post-OLT BBS, approximately half of all patients remained stent-free on an intention-to-treat basis. Stent-related SAEs (especially cholangitis) were common. FCSEMS placement is a viable long-term treatment option for patients with post-OLT BBS. (Clinical trial registration number: NCT01014390.).
Authors: Vasile Sandru; Madalina Stan-Ilie; Oana-Mihaela Plotogea; Catalina Vladut; Bogdan Silviu Ungureanu; Gheorghe G Balan; Dan Ionut Gheonea; Gabriel Constantinescu Journal: Diagnostics (Basel) Date: 2022-05-13