A Randomized Trial Of Rectal Indomethacin To Prevent Post-ERCP Pancreatitis

Objective:To investigate the different clinical effects of preoperative or postoperative rectal indomethacin among patients at high risk for post-ERCP pancreatitis and explore the prevention effect among patients at low risk patients. To observe the clinical effects of routine preoperative rectal indomethacin to prevent post-ERCP pancreatitis.Methods: Patients were randomly divided into preoperative group and postoperative group. Rectal indomethacin(100mg) was administered to preoperative group 30 min prior to ERCP,while patients receive a single dose of rectal Indomethacin(100mg) immediately after ERCP who was at elevated risk for post-ERCP pancreatitis in postoperative group.Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors.All patients were divided into high-risk group or average-risk group according to the standard of risk factors.The levels of serum amylase were detected after 24 hours,and the incidence of panereatitis after the procedure were compared.Results: A total of 932 patients were enrolled,but 17 of them were eliminated according to the standard of rejection. The remaining 915 cases were divided into preoperative group(n=450,127 cases were at high risk and 323 cases were at average risk)and postoperative group(n=465,112 cases were at high risk and 353 cases were at average risk). Post-ERCP pancreatitis developed in 46 of 915 patients(5.0%),16cases(3.6%)were in preoperative group and 30 cases(6.5%)were in postoperative group(P=0.045).Post-ERCP pancreatitis developed in 30 of 676 patients(4.4%) in the average-risk group, 8 of them(2.5%) were in preoperative group and 22 of them(6.2%) were in postoperative group(P=0.018).Post-ERCP pancreatitis developed in 16 of 239 patients(6.7%) in the high-risk group, 8 of them(6.3%) were in preoperative group and 8 of them(7.1%) were in postoperative group(P=0.795).Conclusion:Among patients at average risk for post-ERCP pancreatitis,rectal indomethacin significantly reduced the incidence of the condition.but the clinical effects of preoperative or postoperative rectal indomethacin among patients at high risk for post-ERCP pancreatitis had no significant difference.We suggest that routine preoperative rectal indomethacin could reduce the incidence of post-ERCP pancreatitis to the biggest extent.