Background and Aims: There are so many reports of how to prevent the post ERCP pancreatitis. So many drugs and endoscopic procedures were tried to prevent the post ERCP pancreatitis. Gabexate mesylate or somatostatin was one of the drugs which was used for this purpose. However wheather gabexate mesylate or somatostatin could prevent the post ERCP pancreatitis is still being debated. The aim of this study was to evaluate the effect of combination therapy of gabexate mesylate and somatostatin for the prevention of post ERCP pancreatitis. Methods: In a randomized, double blind, controlled trial, 44 patients undergoing ERCP in our hospital between May 2005 and October 2005 were randomly assigned to intravenous administration of gabexate mesylate (500 mg; n = 16), gabexate mesylate (500 mg) and somatostatin (750 mg; n = 12), and placebo (saline; n = 16). We excluded the patients with previous endoscopic sphincterotomy (EST), chronic pancreatitis, acute pancreatitis and hyperamylasemia. The drug infusion started 30 minutes before ERCP and continued for 6 hours afterward. Patients were evaluated clinically, and serum amylase levels were determined at pre-ERCP and, at 24 hr and 48hr post-ERCP. Results: No significant difference in incidences of abdominal pain or acute pancreatitis and hyperamylasemia including acute pancreatitis were observed among the placebo, gabexate mesylate alone and gabexate mesylate and somatostatin groups. Although there was no statistical significance, 2 cases of post-ERCP pancreatitis occurred only in the placebo group. These patients all had mild pancreatitis and they improved only with medical treatment. In univariate analysis of patients characteristics and ERCP maneuvers, repeated pancreatic duct injection was only significantly associated with post-ERCP hyperamylasemia (p = 0.035), also in multiple logistic regression (p = 0.043). Other variables such as age, sex, periampullary diverticulum, biliary sphincterotomy, CBD stone removal after EST, stent insertion after EST, the size of CBD were not an independent risk factor for post-ERCP pancreatitis. Conclusion: Only repeated pancreatic duct injection significantly associated with post-ERCP hyperamylasemia. This ongoing study appeared to show that prophylactic administration of gabexate mesylate and somatostatin could not reduce post-ERCP pancreatitis. Further more large scale studies would be needed to assess the effect of the combination therapy of gabaxate mesylate and somatostatin for the prevention of post-ERCP pancreatitis.
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