Mohan Ramchandani1, Sundeep Lakhtakia1, Guido Costamagna2, Andrea Tringali2, Andreas Püspöek3, Barbara Tribl4, Werner Dolak4, Jacques Devière5, Marianna Arvanitakis5, Schalk van der Merwe6, Wim Laleman6, Thierry Ponchon7, Vincent Lepilliez7, Armando Gabbrielli8, Laura Bernardoni8, Marco J Bruno9, Jan-Werner Poley9, Urban Arnelo10, James Lau11, André Roy12, Michael Bourke13, Arthur Kaffes14, Horst Neuhaus15, Joyce Peetermans16, Matthew Rousseau16, D Nageshwar Reddy17. 1. Asian Institute of Gastroenterology, Hyderabad, India. 2. Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Roma, Italia. 3. Centre for Endoscopic Research Therapeutics and Training (CERTT), St. John's Hospital, Eisenstadt, Austria. 4. Medizinische Universität Wien, Vienna, Austria. 5. Hôpital Erasme, Brussels, Belgium. 6. University Hospitals Leuven, Leuven, Belgium. 7. Hôpital Edouard Herriot, Lyon, France. 8. Università degli Studi Verona Policlinico G.B. Rossi, Verona, Italy. 9. Erasmus Medical Center, Rotterdam, The Netherlands. 10. CLINTEC, Division of Surgery, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden. 11. Prince of Wales Hospital, New Territories, Hong Kong. 12. Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada. 13. Western Clinical School, University of Sydney, Westmead Hospital, Sydney, NSW, Australia. 14. Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia. 15. Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany. 16. Endoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts. 17. Asian Institute of Gastroenterology, Hyderabad, India. Electronic address: aigindia@yahoo.co.in.
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.).
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.).
Authors: Marko Murruste; Ülle Kirsimägi; Karri Kase; Tatjana Veršinina; Peep Talving; Urmas Lepner Journal: World J Clin Cases Date: 2022-08-06 Impact factor: 1.534