A prospective, randomized, placebo-controlled trial of prednisone and allopurinol in the prevention of ERCP-induced pancreatitis

Background and Study Aims: Acute pancreatitis is the most frequent and difficult-to-avoid complication of endoscopic retrograde cholangiopancreatography (ERCP). Corticosteroids, potent anti-inflammatory drugs, and allopurinol - a xanthine oxidase inhibitor that blocks the generation of oxygen-derived free radicals - may be potentially effective in preventing post-ERCP pancreatitis. The aim of this prospective study was to determine the effect of prophylactic oral corticosteroids and allopurinol on the incidence and severity of procedure-induced pancreatitis. Patients and Methods: 300 patients were randomly assigned to receive oral prednisone (40 mg), allopurinol (200 mg), or placebo 15 h and 3 h prior to ERCP. The diagnosis and grading of ERCP complications were based on commonly accepted criteria. Patients receiving prednisone or allopurinol were compared with the placebo group in a search for differences in pancreatitis rates associated with endoscopic techniques. Results: The overall incidence of pancreatitis was 10.7%, with 12% in the prednisone group, 12.1% in the allopurinol group, and 7.9% in the placebo group. There were no statistical differences in the incidence or distribution of severity grades between the groups, although severe pancreatitis occurred only in the prednisone and allopurinol groups. Multiple cannulations and prolonged manipulations of the papilla of Vater were identified as risk factors for ERCP-induced pancreatitis. Conclusions: Neither prednisone nor allopurinol showed a beneficial influence on the incidence and severity of post-ERCP pancreatitis.