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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial
Gastroenterology, Volume 161, No. 1, Year 2021
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Description
Background & Aims: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients. Methods: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS vs FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events. Results: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs FCSEMS, respectively, stricture resolution status at 24 months was 77.1% (54/70) vs 75.8% (47/62) (P = .008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P < .001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ± .6 (P < .001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P = .568), including cholangitis/fever/jaundice (9 vs 7 patients respectively), abdominal pain (5 vs 5), cholecystitis (1 vs 3) and post-ERCP pancreatitis (0 vs 2). No stent- or procedure-related deaths occurred. Conclusions: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256.) © 2021
Authors & Co-Authors
Ramchandani, Mohan J.
India, Hyderabad
Asian Institute of Gastroenterology India
Lakhtakia, Sundeep
India, Hyderabad
Asian Institute of Gastroenterology India
Costamagna, Guido
Italy, Rome
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Italy, Rome
Università Cattolica Del Sacro Cuore, Campus Di Roma
Tringali, A.
Italy, Rome
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Italy, Rome
Università Cattolica Del Sacro Cuore, Campus Di Roma
Devière, Jacques
Belgium, Brussels
Hôpital Erasme
van der Merwe, Schalk Willem
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Laleman, Wim J.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Ponchon, Thierry
France, Lyon
Hopital Edouard Herriot
Bruno, Marco J.
Netherlands, Rotterdam
Erasmus Mc
Poley, Jan Werner
Netherlands, Rotterdam
Erasmus Mc
Arnelo, Urban
Sweden, Stockholm
Karolinska Institutet
Lau, James Yun Wong
Hong Kong
Prince of Wales Hospital Hong Kong
Roy, Andre F.
Canada, Montreal
Centre Hospitalier de L'universite de Montreal
Bourke, Michael John
Australia, Sydney
Westmead Hospital
Kaffes, Arthur John
Australia, Sydney
Royal Prince Alfred Hospital
Neuhaus, Horst N.
Germany, Dusseldorf
Evangelisches Krankenhaus Düsseldorf
Peetermans, Joyce A.
United States, Marlborough
Boston Scientific Corporation
Rousseau, Matthew John
United States, Marlborough
Boston Scientific Corporation
Reddy, Duvvuru Nageshwar
India, Hyderabad
Asian Institute of Gastroenterology India
Statistics
Citations: 27
Authors: 19
Affiliations: 17
Identifiers
Doi:
10.1053/j.gastro.2021.03.015
ISSN:
00165085
Research Areas
Cancer