BACKGROUND:Acute pancreatitis is a common complication of ERCP, occurring in up to 10% of cases. Chemoprevention of post-ERCP pancreatitis remains a debated issue. OBJECTIVE: This study evaluated whether increased dosage of octreotide, a potent inhibitor of pancreatic secretion, could reduce the incidence of post-ERCP pancreatitis. DESIGN: In a randomized, double-blind, placebo controlled trial, the effect of 500 microg octreotide, given 3 times daily subcutaneously starting 24 hours before the ERCP procedure, was compared with that of placebo in patients who underwent diagnostic and/or therapeutic ERCP. PATIENTS: A total of 202 patients were included in the trial. The 2 groups were similar in regards to age, sex, indications for treatment, underlying diseases, and types of therapeutic procedures. Patients were clinically evaluated, and serum amylase levels were determined before ERCP and at 6 to 8 hours thereafter. Standardized criteria were used to diagnose and to grade the severity of post-ERCP pancreatitis. RESULTS: The medication was discontinued because of an allergic reaction in 1 patient in the octreotide group. The incidence of post-ERCP pancreatitis was significantly lower in the octreotide group compared with the placebo group (2/10 [2%] vs 9/101 [8.9%], P = .03). All cases of acute pancreatitis were mild, except 2 (1 moderate and 1 severe) in the placebo group. CONCLUSIONS: The results of this trial support the use of 24-hour prophylaxis with high dose of octreotide in the prevention of post-ERCP pancreatitis.
RCT Entities:
BACKGROUND: Acute pancreatitis is a common complication of ERCP, occurring in up to 10% of cases. Chemoprevention of post-ERCP pancreatitis remains a debated issue. OBJECTIVE: This study evaluated whether increased dosage of octreotide, a potent inhibitor of pancreatic secretion, could reduce the incidence of post-ERCP pancreatitis. DESIGN: In a randomized, double-blind, placebo controlled trial, the effect of 500 microg octreotide, given 3 times daily subcutaneously starting 24 hours before the ERCP procedure, was compared with that of placebo in patients who underwent diagnostic and/or therapeutic ERCP. PATIENTS: A total of 202 patients were included in the trial. The 2 groups were similar in regards to age, sex, indications for treatment, underlying diseases, and types of therapeutic procedures. Patients were clinically evaluated, and serum amylase levels were determined before ERCP and at 6 to 8 hours thereafter. Standardized criteria were used to diagnose and to grade the severity of post-ERCP pancreatitis. RESULTS: The medication was discontinued because of an allergic reaction in 1 patient in the octreotide group. The incidence of post-ERCP pancreatitis was significantly lower in the octreotide group compared with the placebo group (2/10 [2%] vs 9/101 [8.9%], P = .03). All cases of acute pancreatitis were mild, except 2 (1 moderate and 1 severe) in the placebo group. CONCLUSIONS: The results of this trial support the use of 24-hour prophylaxis with high dose of octreotide in the prevention of post-ERCP pancreatitis.