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

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.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Devière J,Nageshwar Reddy D,Püspök A,Ponchon T,Bruno MJ,Bourke MJ,Neuhaus H,Roy A,González-Huix Lladó F,Barkun AN,Kortan PP,Navarrete C,Peetermans J,Blero D,Lakhtakia S,Dolak W,Lepilliez V,Poley JW,Tringali A,Costam

doi

10.1053/j.gastro.2014.04.043

subject

Has Abstract

pub_date

2014-08-01 00:00:00

pages

385-95; quiz e15

issue

eissn

0016-5085

issn

1528-0012

pii

S0016-5085(14)00599-X

journal_volume

147

pub_type

临床试验,杂志文章,多中心研究

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