Aggressive periprocedural hydration was ineffective at reducing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. These findings, from a multicenter, open-label, randomized, controlled trial, were published in Lancet Gastroenterology and Hepatology.
Patients (N=826) undergoing ERCP with moderate to high risk for post-ERCP pancreatitis at 4 university medical centers and 18 large teaching hospitals in the Netherlands were recruited for the FLUYT (aggressive fluid hydration plus non-steroidal anti-inflammatory drugs [NSAIDs] versus NSAIDs alone for post-ERCP pancreatitis) trial between 2015 and 2019. Randomization occurred in a 1:1 ratio to receive aggressive periprocedural hydration with rectal NSAIDs (n=388) or rectal NSAIDs alone (n=425). The aggressive hydration consisted of 20 mL/kg intravenous Ringer’s lactate solution within 60 minutes of ERCP and 3 mL/kg/hr for 8 hours following procedure. Rectal NSAIDs were defined as 100 mg of diclofenac or indomethacin within 30 minutes of ERCP.
Patients in the hydration and control groups were aged median 57 years (interquartile range [IQR], 44-71 years) and 60 years (IQR, 49-71 years) and 60% and 59% were women, respectively.
Compared with the control group, no differences were observed for risk for post-ERCP pancreatitis (relative risk [RR], 0.84; 95% CI, 0.53-1.33; P =.53), exocrine insufficiency (RR, 0.40; 95% CI, 0.02-7.69; P =.25), or endocrine insufficiency (RR, 1.70; 95% CI, 0.44-6.66; P =.49).
Similarly, group differences were not observed for serious adverse events including ERCP-related complications (RR, 0.90; 95% CI, 0.62-1.31; P =.62), hydration-related complications (RR, 0.99; 95% CI, 0.59-1.64; P =1.00), transfer to intensive care unit (RR, 0.37; 95% CI, 0.07-1.80; P =.22), 180-day mortality (RR, 1.00; 95% CI, 0.45-2.25; P =1.00), and cholangitis at 180 days (RR, 0.68; 95% CI, 0.23-2.08; P =.50).
Post-ERCP pancreatitis risk was not associated with any demographic or clinical subgroups.
This study may have been biased by its open-label design.
These data indicate there was little clinical benefit from aggressive periprocedural hydration prior to ERCP, as it had no preventative effect on post-ERCP pancreatitis among patients who were at moderate to high risk for developing the condition. The study authors could not recommend this course of treatment among this patient population.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Weiland C J S, Smeets X J N M, Kievit W, et al. 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. Lancet Gastroenterol Hepatol. Published online March 19, 2021. doi: 10.1016/S2468-1253(21)00057-1