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

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 161; no. 1; pp. 185 - 195
• Main Authors: Ramchandani, Mohan, Lakhtakia, Sundeep, Costamagna, Guido, Tringali, Andrea, Püspöek, Andreas, Tribl, Barbara, Dolak, Werner, Devière, Jacques, Arvanitakis, Marianna, van der Merwe, Schalk, Laleman, Wim, Ponchon, Thierry, Lepilliez, Vincent, Gabbrielli, Armando, Bernardoni, Laura, Bruno, Marco J., Poley, Jan-Werner, Arnelo, Urban, Lau, James, Roy, André, Bourke, Michael, Kaffes, Arthur, Neuhaus, Horst, Peetermans, Joyce, Rousseau, Matthew, Reddy, D. Nageshwar
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2021
• Subjects: Adult; Aged; Benign Biliary Strictures; Biliary Stenting; Cholestasis - diagnostic imaging; Cholestasis - etiology; Cholestasis - therapy; Chronic Pancreatitis; Coated Materials, Biocompatible; Drainage - adverse effects; Drainage - instrumentation; Female; Humans; Male; Medicin och hälsovetenskap; Middle Aged; Pancreatitis, Chronic - complications; Pancreatitis, Chronic - diagnosis; Plastic Stents; Plastics; Prosthesis Design; Randomized Trial; Self Expandable Metallic Stents; Stents; Treatment Outcome; Benign Biliary Strictures; RCT; Plastic Stents; Self-Expandable Metallic Stents; ITT; IQR; CDM; CP; MPS; Biliary Stenting; BBS; Chronic Pancreatitis; SAE; Randomized Trial; ERCP; FCSEMS
• ISSN: 0016-5085; 1528-0012; 1528-0012
• DOI: 10.1053/j.gastro.2021.03.015

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. 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. 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. 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.) [Display omitted] For benign biliary stricture secondary to chronic pancreatitis, 12-month endotherapy using a single fully covered self-expandable metal stent has similar efficacy and safety and requires fewer procedural interventions than multiple plastic stents.