A multicenter, randomized, controlled trial to evaluate the effect of prophylactic octreotide on ERCP-induced pancreatitis.

Eight-four patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) were randomized to receive 100 micrograms of octreotide intravenously immediately prior to ERCP, and 100 micrograms subcutaneously 45 min after the initial dose, or placebo. Amylase, lipase, and glucose were measured and clinical assessment was performed before, and 2 and 24 h after, ERCP. We define clinical pancreatitis as the combination of elevated amylase or lipase with abdominal pain and tenderness. Interim analysis in 84 patients revealed an 11% incidence of clinical pancreatitis in the control group and 35% in the treatment group (p < 0.01). There were no differences in either group with respect to sphincterotomy, gender, age, duration of ERCP, number of cannulations of the pancreatic duct, degree of duct injection, or the volume of contrast injected. Analysis of group differences stratified by sphincterotomy revealed the following: 1) In patients who did not undergo a sphincterotomy, there was a significantly higher rate of pancreatitis in the treatment group [10/17 (59%) versus 1/17 (6%) RR 10.0 (95% CI 1.4-69.8)]. 2) Sphincterotomy reduced the rate of pancreatitis in patients who received octreotide from 10/17 (59% no sphincterotomy), to 3/20 (15% sphincterotomy) (p = 0.01), which equals the rate in patients who received placebo and underwent sphincterotomy [4/25 (16%)]. 3) Although the incidence of pancreatitis was higher in the treatment group, octreotide may reduce the severity of pancreatitis measured by the number of days NPO (Wilcoxon rank sum, p = 0.02), length of stay after ERCP (p = 0.13), the number of days of pain (p = 0.11), and the degree of amylase elevation (p = 0.04). We conclude that: 1) Octreotide appears to increase the incidence of pancreatitis when given prophylactically for diagnostic ERCP. 2) Although pancreatitis was more common in the octreotide group, it was less severe than the placebo group. 3) Sphincterotomy may afford protection against pancreatitis in patients who received octreotide. 4) We cannot recommend the use of prophylactic octreotide during diagnostic or therapeutic ERCP.