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

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).