Dr. Moulder
Clinical question: Does the addition of aggressive intravenous hydration to rectal nonsteroidal anti-inflammatory drugs (NSAIDs) help prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis?
Background: Pancreatitis is a common complication of ERCP. The use of prophylactic rectal NSAIDs reduces the development of post-ERCP pancreatitis. Evidence has emerged that aggressive periprocedural hydration using lactated Ringer’s solution reduces the risk of post-ERCP pancreatitis, though this was not studied in combination with rectal NSAIDs.
This trial aimed to evaluate the value of aggressive hydration in combination with prophylactic NSAIDS to prevent post-ERCP pancreatitis.
Study design: The Fluid Hydration to Prevent Post-ERCP Pancreatitis In Average- To High-Risk Patients Receiving Prophylactic Rectal NSAIDS Trial (FLUYT) was a multicenter, open-label, randomized, controlled trial.
Setting: The trial was conducted by the Dutch Pancreatitis Study group comprising four university medical centers and 18 teaching hospitals in the Netherlands between June 2015 and June 2019.
Synopsis: In this trial, 826 patients undergoing ERCP, aged 18 to 85, with moderate to high risk of post-ERCP pancreatitis, were randomized to receive aggressive periprocedural hydration (20 mL/kg intravenous lactated Ringer’s within 60 minutes of the start of ERCP, followed by 3 mL/kg/hour for 8 hours) in addition to rectal NSAIDs (100 mg of diclofenac or indomethacin). The primary endpoint analyzed on a modified intention-to-treat basis was post-ERCP pancreatitis and secondary endpoints were severity of post-ERCP pancreatitis, ERCP-related complications, hydration-related complications, pancreatic insufficiency, and duration of hospital stay. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and 39 (9%) patients in the control group.
There were no differences in serious adverse events including hydration-related complications, intensive care unit admission, and 30-day mortality. These results reassure us that there is no reduction in the incidence of post-ERCP pancreatitis when aggressive hydration is added to prophylactic NSAIDs.
Bottom line: Combination therapy of aggressive periprocedural hydration with lactated Ringer’s in addition to rectal NSAIDs was not superior to rectal NSAIDs alone in reducing the incidence of post-ERCP pancreatitis in patients at moderate risk of developing this complication.
Citation: Sperna Weiland CJ, 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. 2021;6(5):350-8.
Dr. Moulder is an assistant professor of medicine at the University of Virginia School of Medicine, Charlottesville, Va.