Octreotide 24-h prophylaxis in patients at high risk for post-ERCP pancreatitis: Results of a multicenter, randomized, controlled trial

Background: Pharmacological prophylaxis of post-ERCP pancreatitis is costly and not useful in most non-selected patients, in whom the incidence of pancreatitis is 5% or less. However, it could be useful and probably cost-effective, in patients at high risk for this complication, where the post-procedure pancreatitis rate is 10% and more. Aim: To assess the efficacy of octreotide in reducing the incidence and severity of post-ERCP pancreatitis and procedure-related hospital stay, in subjects with known patient-related risk factors. Methods: A total of 120 patients were randomly allocated to receive octreotide or not, in a multicentre, randomized, controlled trial. The drug was given subcutaneously, 200 μg t.d.s., starting 24 h before the ERCP procedure, in patients with either sphincter of Oddi dysfunction, or a history of relapsing pancreatitis or post-ERCP pancreatitis, or who were aged under 35 years, or who had a small common bile duct diameter <8 mm). Results: A total of 114 patients (58 in the octreotide group and 56 in the control group) completed the trial. Post-procedure pancreatitis occurred in seven octreotide-treated patients (12.0%) and eight controls (14.3%). The two groups showed no significant differences in the incidence or severity of pancreatitis. Twenty-four hours after the procedure, severe hyperamylasemia (more than five times the upper normal limit) without pancreatic-like pain was recorded in three octreotide-treated patients (5.2%) and six controls (10.7%), the difference being not significant. Conclusion: Twenty-four-hour prophylaxis with octreotide proved ineffective in preventing post-ERCP pancreatitis and in avoiding 24-h severe hyperamylasemia in high-risk patients.