Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study

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Gastrointestinal Endoscopy Volume 65, Issue 7, June 2007, Pages 982-987

Abstract

doi:10.1016/j.gie.2007.02.055 Copyright © 2007 American Society for Gastrointestinal Endoscopy Published by Mosby, Inc.

Original Article

Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study

Gianpiero Manes MD, a, Sandro Ardizzone MDa, Giovanni Lombardi MDa, Generoso Uomo MDa, Oreste Pieramico MDa and e Bianchi Porro PhDa aCurrent affiliations: Department of Gastroenterology, University Hospital L. Sacco, Milano (G.M., S.A., G.B.P.), Department of Gastroenterology and Internal Medicine, Cardarelli Hospital, Napoli (G.L., U.G.), Department of Internal Medicine, Tappeiner Hospital, Merano (O.P.), Italy Received 25 August 2006; accepted 27 February 2007. Milano, Napoli, Merano, Italy. Available online 24 May 2007.

Background and Objective Gabexate mesylate reduces the incidence of post-ERCP pancreatitis. Patient-related risk factors associated with pancreatitis can be identified before ERCP, but the procedure-related factors are recognized only at the end of the procedure. This study's aim was to evaluate whether gabexate mesylate administered after ERCP reduces the incidence of pancreatitis. Design Randomized, prospective, double-blind, multicenter trial. Setting Tertiary care centers. Patients and Intervention A total of 608 patients undergoing ERCP were treated with gabexate mesylate 500 mg within 1 hour before ERCP (group A, 203 patients) or within 1 hour after ERCP (group B, 203), or with saline solution (group C, 202). Main Outcome Measurements The incidence and severity of pancreatitis and hyperamylasemia, as well as factors associated with the development of pancreatitis. Results The groups were similar for demographic characteristics, indications to ERCP, risk factors for pancreatitis, and therapeutic procedures. The incidence of pancreatitis was 3.9% in group A, 3.4% in group B, and 9.4% in group C (P < .01). Two patients (in groups A and C) developed necrotizing pancreatitis, and 1 died. Hyperamylasemia occurred in 23.6% in groups A and B, and in 24.7% in group C. Levels of amylase, the incidence of abdominal pain, and other complications occurred similarly. Female sex (odds ratios [OR] 2.7, 95% CI 1.2-5.9) and difficult cannulation (OR 5.6, 95% CI 2.6-12.3) were independently associated with pancreatitis. Conclusions The administration of gabexate mesylate after ERCP protects against the development of pancreatitis similarly to the preprocedure administration. Factors associated with pancreatitis were mainly recognized after ERCP. We suggest administering gabexate mesylate after ERCP only in those patients recognized to be at risk of developing pancreatitis.

Reprint requests: Gianpiero Manes, MD, Divisione e Cattedra di Gastroenterologia, Ospedale Universitario L. Sacco, Via G. B. Grassi 74, 20157 Milano, Italy.

Gastrointestinal Endoscopy Volume 65, Issue 7, June 2007, Pages 982-987