A Randomised Trial of Aggressive Fluid Hydration to Prevent Post-ERCP Pancreatitis (FLUYT)

Aims Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (rNSAIDs) administration is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration may further reduce this risk. Guidelines already recommend aggressive hydration. However, multicentre randomised trials studying the added value of aggressive hydration in patients receiving prophylactic rNSAIDs are lacking. We, therefore, performed a trial to investigate the combination of aggressive hydration and rNSAIDs.

Methods In this multicentre, parallel-group open-label randomised controlled superiority trial, patients with moderate- to high-risk of post-ERCP pancreatitis were assessed for eligibility in 22 Dutch hospitals. Patients were randomly assigned (1:1) to a combination of aggressive hydration and rNSAIDs or rNSAIDs monotherapy. Aggressive hydration comprised 20mL/kg lactated Ringer’s intravenously from the start of ERCP within 60 minutes, followed by 3mL/kg/h for 8 hours. The control group received normal saline with a maximum of 1.5mL/kg/h and 3L/24h. The primary endpoint was post-ERCP pancreatitis. Secondary endpoints included pancreatitis severity and ERCP- and hydration-related complications. ISRCTN registry: ISRCTN13659155.

Results A total of 826 patients were randomised. Patient baseline and ERCP characteristics were similar in both groups. Post-ERCP pancreatitis developed in 30 of 388 patients (8 %) in the hydration group and in 39 of 425 patients (9 %) in the control group (RR, 0.84; 95 %CI [0.53-1.33]; P = 0.53). 21 patients (5 %) in the hydration group and in 32 patients (8 %) in the control group (P = 0.39) developed a moderate-to-severe pancreatitis. ERCP- and hydration-related complications did not differ between both groups (P = 0.6 and P = 1.0, respectively). There were no differences in other secondary endpoints, including serious adverse events.

Conclusions The combination of rNSAIDs and aggressive periprocedural hydration was not superior in reducing the incidence of post-ERCP pancreatitis, as compared to rNSAID monotherapy in patients with moderate- to high- risk of post-ERCP pancreatitis.

Citation: Sperna Weiland CJ, Smeets XJ, Kievit W et al. OP63 A RANDOMISED TRIAL OF AGGRESSIVE FLUID HYDRATION TO PREVENT POST-ERCP PANCREATITIS (FLUYT). Endoscopy 2021; 53: S26.

Publication History

Article published online:
19 March 2021