title: Successful management of benign biliary strictures with fully covered self-expanding metal stents.
abstract: OBJECTIVE
  Fully covered self-expanding metal stents (FCSEMS) are gaining acceptance for the treatment of benign biliary strictures. We performed a large prospective multinational study to study the ability to remove these stents after extended indwell and the frequency and durability of stricture resolution.
  
  
  METHODS
  In a nonrandomized study at 13 centers in 11 countries, 187 patients with benign biliary strictures received FCSEMS. Removal was scheduled at 10-12 months for patients with chronic pancreatitis or cholecystectomy and at 4-6 months for patients who received liver transplants. The primary outcome measure was removal success, defined as either scheduled endoscopic removal of the stent with no removal-related serious adverse events or spontaneous stent passage without the need for immediate restenting.
  
  
  RESULTS
  Endoscopic removal of FCSEMS was not performed for 10 patients because of death (from unrelated causes), withdrawal of consent, or switch to palliative treatment. For the remaining 177 patients, removal success was accomplished in 74.6% (95% confidence interval [CI], 67.5%-80.8%). Removal success was more frequent in the chronic pancreatitis group (80.5%) than in the liver transplantation (63.4%) or cholecystectomy (61.1%) groups (P = .017). FCSEMS were removed by endoscopy from all patients in whom this procedure was attempted. Stricture resolution without restenting upon FCSEMS removal occurred in 76.3% of patients (95% CI, 69.3%-82.3%). The rate of resolution was lower in patients with FCSEMS migration (odds ratio, 0.22; 95% CI, 0.11-0.46). Over a median follow-up period of 20.3 months (interquartile range, 12.9-24.3 mo), the rate of stricture recurrence was 14.8% (95% CI, 8.2%-20.9%). Stent- or removal-related serious adverse events, most often cholangitis, occurred in 27.3% of patients. There was no stent- or removal-related mortality.
  
  
  CONCLUSIONS
  In a large prospective multinational study, removal success of FCSEMS after extended indwell and stricture resolution were achieved for approximately 75% of patients. ClincialTrials.gov number, NCT01014390.
authors.affiliation: Service de Gastro-Entérologie et d'Hépato-Pancréatologie, Université Libre de Bruxelles, Hôpital Erasme, Brussels, Belgium. Electronic address: Jacques.Deviere@erasme.ulb.ac.be.
authors.forename: Jacques
authors.initials: J
authors.lastname: Devière
authors.affiliation: Gastroenterology and Therapeutic Endoscopy, Asian Institute of Gastroenterology, Hyderabad, India.
authors.forename: D
authors.initials: D
authors.lastname: Nageshwar Reddy
authors.affiliation: Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Vienna, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Püspök
authors.affiliation: Service de Gastroentérologie et d'Endoscopie Digestive, Hôpital Edouard Herriot, Lyon, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Ponchon
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus Medical Center, University of Rotterdam, Rotterdam, The Netherlands.
authors.forename: Marco J
authors.initials: MJ
authors.lastname: Bruno
authors.affiliation: Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, New South Wales, Australia.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Bourke
authors.affiliation: Medizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Neuhaus
authors.affiliation: Département de Chirurgie, Hôpital Saint-Luc, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
authors.forename: André
authors.initials: A
authors.lastname: Roy
authors.affiliation: Unidad de Endoscopia, Servicio de Aparato Digestivo, Hospital Universitari Doctor Josep Trueta, Girona, Catalunya, Spain.
authors.forename: Ferrán
authors.initials: F
authors.lastname: González-Huix Lladó
authors.affiliation: Division of Gastroenterology, McGill University Health Center, McGill University, Montréal, Québec, Canada.
authors.forename: Alan N
authors.initials: AN
authors.lastname: Barkun
authors.affiliation: Division of Gastroenterology, Centre for Therapeutic Endoscopy and Endoscopic Oncology, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Paul P
authors.initials: PP
authors.lastname: Kortan
authors.affiliation: Servicio de Endoscopía, Clínica Alemana de Santiago, Santiago, Chile.
authors.forename: Claudio
authors.initials: C
authors.lastname: Navarrete
authors.affiliation: Endoscopy Division, Boston Scientific Corp, Natick, Massachusetts.
authors.forename: Joyce
authors.initials: J
authors.lastname: Peetermans
authors.affiliation: Service de Gastro-Entérologie et d'Hépato-Pancréatologie, Université Libre de Bruxelles, Hôpital Erasme, Brussels, Belgium.
authors.forename: Daniel
authors.initials: D
authors.lastname: Blero
authors.affiliation: Gastroenterology and Therapeutic Endoscopy, Asian Institute of Gastroenterology, Hyderabad, India.
authors.forename: Sundeep
authors.initials: S
authors.lastname: Lakhtakia
authors.affiliation: Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Vienna, Austria.
authors.forename: Werner
authors.initials: W
authors.lastname: Dolak
authors.affiliation: Service de Gastroentérologie et d'Endoscopie Digestive, Hôpital Edouard Herriot, Lyon, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Lepilliez
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus Medical Center, University of Rotterdam, Rotterdam, The Netherlands.
authors.forename: Jan W
authors.initials: JW
authors.lastname: Poley
authors.affiliation: L'Unità Operativa di Endoscopia Digestiva Chirurgica, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Tringali
authors.affiliation: L'Unità Operativa di Endoscopia Digestiva Chirurgica, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
mesh_terms: D000328:Adult; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000295:instrumentation*; D002763:Cholecystectomy / Q000009:adverse effects; D002779:Cholestasis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D003251:Constriction, Pathologic; D020878:Device Removal / Q000009:adverse effects; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology; D006801:Humans; D016031:Liver Transplantation / Q000009:adverse effects; D008297:Male; D008670:Metals; D008875:Middle Aged; D050500:Pancreatitis, Chronic / Q000150:complications; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals
keywords: Cholecystectomy; Chronic Pancreatitis; Orthotopic Liver Transplantation; Stent Removal