The safety and efficacy of Ringer's solution loading with rectal diclofenac for prevention of post‐endoscopic retrograde cholangiopancreatography pancreatitis: The RESOLUTION‐PEP study

OBJECTIVES: We evaluated the safety and efficacy of aggressive hydration with rectal non‐steroidal anti‐inflammatory drugs for the prevention of post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS: This prospective, single‐arm, multicenter trial was conducted at 12 institutions between October 2020 and August 2021. We enrolled 231 patients who had intact papillae and were scheduled to undergo ERCP. All patients were administered rectal diclofenac before ERCP. They received aggressive hydration with intravenous lactated Ringer's solution in an initial bolus of 5 ml/kg at the start of ERCP, followed by 3 ml/kg/h for 8 h after the procedure. The primary outcome was the occurrence of PEP. Secondary outcomes included PEP severity, hyperamylasemia, and adverse events. RESULTS: The mean age of the patients was 68.8 ± 13.7 years, and 81 patients (35.1%) were 75 years or older. Thirteen patients developed PEP (5.6%, 95% confidence interval 3.0%–9.4%). There were 11 cases (4.8%) of mild pancreatitis and two cases (0.9%) of severe pancreatitis. Forty‐five patients (19.5%) developed hyperamylasemia and one patient developed non‐severe peripheral edema. CONCLUSIONS: Aggressive hydration combined with rectal diclofenac may be a promising strategy for the prevention of PEP. Furthermore, it is safe even for older individuals.