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 versus 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 ERCPs and stents, and stent- or procedure-related serious adverse events (SAEs).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=0.008 for noninferiority ITT analysis), mean number of ERCPs was 3.9±1.3 vs. 2.6±1.3 (P<0.001, ITT), and mean number of stents placed was 7.0±4.4 vs. 1.3±0.6 (P<0.001, as-treated). SAEs occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P=0.568), 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 to a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256).
Ramchandani, M., Lakhtakia, S., Costamagna, G., Tringali, A., Püspöek, A., Tribl, B., Dolak, W., Devière, J., Arvanitakis, M., Van Der Merwe, S., Laleman, W., Ponchon, T., Lepilliez, V., Gabbrielli, A., Bernardoni, L., Bruno, M. J., Poley, J., Arnelo, U., Lau, J., Roy, A., Bourke, M., Kaffes, A., Neuhaus, H., Peetermans, J., Rousseau, M., Reddy, N., Fully Covered Self-Expanding Metal Stent versus Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial, <<GASTROENTEROLOGY>>, 2021; (n/A): N/A-N/A. [doi:10.1053/j.gastro.2021.03.015] [http://hdl.handle.net/10807/177691]
Fully Covered Self-Expanding Metal Stent versus Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial
Costamagna, Guido;Tringali, Andrea;
2021
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 versus 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 ERCPs and stents, and stent- or procedure-related serious adverse events (SAEs).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=0.008 for noninferiority ITT analysis), mean number of ERCPs was 3.9±1.3 vs. 2.6±1.3 (P<0.001, ITT), and mean number of stents placed was 7.0±4.4 vs. 1.3±0.6 (P<0.001, as-treated). SAEs occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P=0.568), 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 to a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256).
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