Octreotide versus hydrocortisone versus placebo in the prevention of post-ERCP pancreatitis: a multicenter randomized controlled trial

Background: Octreotide is a potent inhibitor of pancreatic secretion, and corticosteroids suppress humoral and cellular activity. Both agents may reduce the frequency of post-ERCP pancreatitis. The aim of this study was to determine the effectiveness of octreotide and hydrocortisone in preventing post-ERCP pancreatitis. Methods: Three hundred fifty-four patients were entered in to a multicenter randomized controlled trial of 100 mug subcutaneous octreotide (Group 1) versus 100 mg intravenous hydrocortisone (Group 2) versus normal saline solution as placebo (Group 3). All medications were administered approximately 30 minutes before the procedure. Patients were assessed clinically and serum amylase was also measured before the procedure and 3,12, and 24 hours after the procedure. Results: Three hundred forty patients were included in the analysis. Pancreatitis was observed in 11 of 112 patients (9.8%) in Group 1, 8 of 113 (7.1%) patients in Group 2, and in 15 of 115 (13.0%) patients in Group 3 (p = 0.32). The mean length of hospitalization in days was similar in all 3 groups: mean (SD) for Groups 1, 2, and 3 were, respectively, 3.6 (1.6) versus 2.9 (0.6) versus 4.3 (1.8) (p = 0.13). Multivariate logistic regression analysis showed that number of pancreatic injections, suspicion of sphincter dysfunction, therapeutic procedure, and age were risk factors for pancreatitis. Conclusions: The results of this trial indicate that octreotide and hydrocortisone do not prevent ERCP-induced pancreatitis.