Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial - PubMed (original) (raw)

Comparative Study

. 2021 Jul;161(1):185-195.

doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.

Sundeep Lakhtakia 1, Guido Costamagna 2, Andrea Tringali 2, Andreas Püspöek 3, Barbara Tribl 4, Werner Dolak 4, Jacques Devière 5, Marianna Arvanitakis 5, Schalk van der Merwe 6, Wim Laleman 6, Thierry Ponchon 7, Vincent Lepilliez 7, Armando Gabbrielli 8, Laura Bernardoni 8, Marco J Bruno 9, Jan-Werner Poley 9, Urban Arnelo 10, James Lau 11, André Roy 12, Michael Bourke 13, Arthur Kaffes 14, Horst Neuhaus 15, Joyce Peetermans 16, Matthew Rousseau 16, D Nageshwar Reddy 17

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Comparative Study

Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial

Mohan Ramchandani et al. Gastroenterology. 2021 Jul.

Abstract

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.).

Keywords: Benign Biliary Strictures; Biliary Stenting; Chronic Pancreatitis; Plastic Stents; Randomized Trial; Self-Expandable Metallic Stents.

Copyright © 2021. Published by Elsevier Inc.

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