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 pan creatitis is 5% or less. However, it could be useful and probably cost-effe ctive, in patients at high risk: for this complication, where the post-proc edure pancreatitis rate is 10% and more. Aim: To assess the efficacy of octreotide in reducing the incidence and sev erity of post-ERCP pancreatitis and procedure-related hospital stay, in sub jects with known patient-related risk factors. Methods: A total of 120 patients were randomly allocated to receive octreot ide or not, in a multicentre, randomized, controlled trial. The drug was gi ven subcutaneously, 200 mug t.d.s., starting 24 h before the ERCP procedure , in patients with either sphincter of Oddi dysfunction, or a history of re lapsing pancreatitis or post-ERCP pancreatitis, or who were aged under 35 y ears, 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 o f pancreatitis. Twenty-four hours after the procedure, severe hyperamylasem ia (more than five times the upper normal limit) without pancreatic-like pa in was recorded in three octreotide-treated patients (5.2%) and six control s (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 hyperamyl asemia in high-risk patients.