Background
/Aims: Gabexate, a protease inhibitor, has been known to prevent pancreatic damage following ERCP. We conducted a prospective and randomized study to assess the preventive effect of gabexate. Methods: Of the 96 patients enrolled, 46 were treated with gabexate and 50 with placebo. The groups were similar with regard to sex, age, body-mass index, and the final diagnosis of ERCP. Results: 24 patients (25.0%) had elevated pancreatic-enzyme levels; the frequency was similar in the two groups (P=0.48). Mean serum amylase value at 4 hours after ERCP was similar in patients with elevated basal level (220.5±43.2 U/L) and those with normal basal level (170.4±31.2 U/L). After the procedures, serum amylase values were lower in the gabexate group (137.1±19.8 U/L) than in the placebo group (212.0±50.4 U/L). The differences were not significant in the mean levels of amylase between the groups for any of imaging of the pancreatic ducts (pancreatic-duct imaging, 201.5±49.4 U/L, bile-duct imaging, 153.7±30.0 U/L). But in the patients with pancreatic duct imaging, serum amylase values were significantly higher in the placebo group (295.0±97.6 U/L) than in the gabexate group (112.0±10.6 U/L)(p<0.05). Conclusions: Prophylactic treatment witd gabexate does not reduce pancreatic damage related to ERCP, but only in the patients with pancreatic duct imaging there were the significant differences between in the gabexate group and in the placebo group.