Background: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is a common complication of therapeutic endoscopy. The aim of this trial was to determine whether a combination of rectal diclofenac and vigorous hydration with Ringer's lactate is superior to the corresponding individual treatments for preventing PEP in high-risk patients. Methods: This randomized, open-label, controlled trial was conducted from August 2020 to January 2022. We included patients who were at high risk of developing PEP. Three intervention groups were made: group A, diclofenac sodium suppository (100 mg); group B, aggressive hydration with Ringer's lactate; group C, a combination of diclofenac and aggressive hydration. PEP was defined as a serum amylase level > 3 times the upper limit of normal with epigastric pain within 24 hours after endoscopic retrograde cholangiopancreatography. Results: A total of 144 patients were included and 48 cases were randomized to each intervention group. The incidence of PEP was 8.3%, 10.4%, and 8.3% in groups A, B, and C, respectively. A personal history of alcohol consumption and more than one pancreatic duct guidewire cannulation were significantly associated with the development of PEP. Conclusion: No difference in the incidence of PEP was observed with or without the use of aggressive hydration. Combining aggressive hydration with a rectal nonsteroidal anti-inflammatory drug for preventing PEP cannot be recommended.
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