Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial

Background Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration non-steroidal anti-inflammatory drugs (NSAIDs) considered as standard care to reduce risk post-ERCP pancreatitis. It has been suggested that aggressive hydration might further this risk. Guidelines already recommend in patients who are unable receive NSAIDs, although it laborious and time consuming. We aimed evaluate added value receiving prophylactic NSAIDs. Methods FLUYT, a multicentre, open-label, randomised, controlled trial done across 22 Dutch hospitals, included aged between 18 85 years with moderate high Patients were randomly assigned (1:1) by web-based module varying block sizes combination NSAIDs (100 mg diclofenac or indomethacin; group) indomethacin) alone (control group). Randomisation was stratified according treatment centre. Aggressive comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from start ERCP, followed 3 per h for 8 h. The control group received normal saline maximum 1·5 L 24 primary endpoint pancreatitis analysed on modified intention-to-treat basis (including all underwent randomisation an ERCP whom data regarding outcome available). registered ISRCTN registry, ISRCTN13659155. Findings Between June 5, 2015, 6, 2019, 826 assigned, 388 425 analysis. Post-ERCP occurred 30 (8%) 39 (9%) (relative 0·84, 95% CI 0·53–1·33, p=0·53). There no differences serious adverse events, including hydration-related complications 0·99, 0·59–1·64; p=1·00), ERCP-related (0·90, 0·62–1·31; p=0·62), intensive unit admission (0·37, 0·07–1·80; p=0·22), 30-day mortality (0·95, 0·50–1·83; p=1·00). Interpretation periprocedural did not incidence developing routinely Therefore, burden time-consuming justified. Funding Netherlands Organisation Health Research Development Radboud University Medical Center.