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Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.

Successful management of benign biliary strictures with fully covered self-expanding metal stents.

Author information

1
Service de Gastro-Entérologie et d'Hépato-Pancréatologie, Université Libre de Bruxelles, Hôpital Erasme, Brussels, Belgium. Electronic address: Jacques.Deviere@erasme.ulb.ac.be.
2
Gastroenterology and Therapeutic Endoscopy, Asian Institute of Gastroenterology, Hyderabad, India.
3
Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Vienna, Austria.
4
Service de Gastroentérologie et d'Endoscopie Digestive, Hôpital Edouard Herriot, Lyon, France.
5
Department of Gastroenterology and Hepatology, Erasmus Medical Center, University of Rotterdam, Rotterdam, The Netherlands.
6
Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, New South Wales, Australia.
7
Medizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.
8
Département de Chirurgie, Hôpital Saint-Luc, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
9
Unidad de Endoscopia, Servicio de Aparato Digestivo, Hospital Universitari Doctor Josep Trueta, Girona, Catalunya, Spain.
10
Division of Gastroenterology, McGill University Health Center, McGill University, Montréal, Québec, Canada.
11
Division of Gastroenterology, Centre for Therapeutic Endoscopy and Endoscopic Oncology, St. Michael's Hospital, Toronto, Ontario, Canada.
12
Servicio de Endoscopía, Clínica Alemana de Santiago, Santiago, Chile.
13
Endoscopy Division, Boston Scientific Corp, Natick, Massachusetts.
14
Service de Gastro-Entérologie et d'Hépato-Pancréatologie, Université Libre de Bruxelles, Hôpital Erasme, Brussels, Belgium.
15
L'Unità Operativa di Endoscopia Digestiva Chirurgica, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.

Abstract

BACKGROUND & AIMS:

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.

KEYWORDS:

Cholecystectomy; Chronic Pancreatitis; Orthotopic Liver Transplantation; Stent Removal

PMID:
24801350
DOI:
10.1053/j.gastro.2014.04.043
[Indexed for MEDLINE]

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