GABEXATE FOR THE PREVENTION OF PANCREATIC DAMAGE RELATED TO ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY

Background Endoscopic retrograde cholangiopancreatography (ERCP) is as sociated with elevated levels of pancreatic enzymes and pancreatitis. Gabexate, a protease inhibitor, has been used to prevent pancreatic da mage related to ERCP. Methods We conducted a multicenter, double-blind comparison of gabexate (1 g given by intravenous infusion starting 30 to 90 minutes before endoscopy and continuing for 12 hours afterward) with placebo (mannitol and sodium chloride, administered in the same fashion). A total of 435 adults scheduled to undergo ERCP and, when in dicated, endoscopic sphincterotomy underwent randomization; 17 were ex cluded from the final analysis for various reasons. The remaining 418 patients (mean age, 60.4 years) - 208 in the gabexate group and 210 in the placebo group - were analyzed. Acute pancreatitis was considered to be present if serum amylase or lipase levels (or both) were five ti mes greater than the upper limits of normal in association with the on set of pancreatic pain, Results After the procedures, 276 patients (66 percent) had elevated pancreatic-enzyme levels; the frequency was sim ilar in the two groups. Mean serum amylase values were higher in the p lacebo group than in the gabexate group through 24 hours of observatio n (P=0.03). Twelve patients in the gabexate group and 29 in the placeb o group had abdominal pain (6 percent vs. 14 percent, P=0.009). Sixtee n patients in the placebo group and five in the gabexate group had acu te pancreatitis (8 percent vs. 2 percent, P=0.03). Two patients treate d with gabexate and six given placebo had adverse events, all of which resolved, Two patients given placebo died of acute pancreatitis; one was excluded from the evaluation because pancreatitis was present befo re endoscopy. One patient in the gabexate group died, from a myocardia l infarction. Conclusions Prophylactic treatment with gabexate reduced pancreatic damage related to ERCP, as reflected by reductions in the extent but not the frequency of elevated enzyme levels and in the freq uency of pancreatic pain and acute pancreatitis.