Prophylaxis of Post-ERCP Pancreatitis Using Temporary Pancreatic Stent vs Rectal Nonsteroidal Anti-Inflammatory Drug: a Randomized Controlled Trial

Background: Placement of pancreatic stents prevents post-ERCP pancreatitis (PEP). There is evidence that rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) also prevents PEP, but the 2 approaches alone have not been compared directly. The aim of this study was to compare the efficacies of these procedures to prevent PEP in Japanese populations. Methods: Thirty six patients undergoing ERCP mainly for the therapy of common bile duct stones were studied. The study group included the patients at high risk for PEP because of a difficult cannulation, precut sphincterotomy, and/or pancreatic duct injection. Each patient was randomly allocated to receive pancreatic stent placement (n=12), administration of 50 mg diclofenac (n=12), or both (n=12) to prevent PEP. The stent used was a 5F, 3-cm long pancreatic stent without an inner flange, which was dislodged spontaneously. The diclofenac was administered rectally immediately after ERCP. The primary endpoint of this study was the frequency of PEP, and the secondary outcome included mean serum amylase level after the procedures in each treatment group. Results: Pancreatic stents were placed successfully in 88% of the cases (21/24). One patient developed mild PEP, who was administered 50 mg diclofenac. There were no significant differences in the frequency of PEP and mean serum amylase level after the procedures among the three groups. Conclusion: The rectal administration of 50 mg diclofenac may be effective to prevent PEP in Japanese populations when the pancreatic stent placement fails. However, further accumulation of the cases is needed in order to make a clear conclusion.