NSAIDs are not enough - a double blinded randomized controlled trial on the impact of intensive hydration for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis

Background Pancreatitis is the most common complication following endoscopic retrograde cholangiopancreatography (ERCP). In patients receiving NSAID prophylaxis, we aimed to assess whether periprocedural intensive hydration (IH) resulted in a lower incidence of PEP when compared to standard hydration (SH). Material and Methods Prospective, single-center, double-blinded randomized controlled trial, with inclusion of consecutive patients submitted to inaugural ERCP between January 2015 and December 2018. Patients were randomized on admission, in a 1:1 ratio, to either SH-Ringer's Lactate (RL) at a rate of 1.5 mL/kg/h during and for 8 h following the procedure, or IH-RL at a rate of 3 mL/kg/h during and for 8 h following the procedure, with an additional bolus of 20 mL/kg at the end of the procedure. PEP incidence and severity were assessed according to the Atlanta Guidelines. Results A total of 155 patients were randomized (83 to IH, 72 to SH). PEP was observed in 8,4% (n = 13) of the patients, and was significantly less frequent in IH patients when compared to SH (3,6% vs 13,9%, P = 0,021; relative risk 0.233 [95% IC, 0.061-0.881]); five patients in the SH group developed moderate to severe PEP, in contrast to 0 patients in the IH group (6.9% vs 0.0%, P = 0,020). Conclusions Intensive hydration significantly decreased the risk of post-ERCP pancreatitis by four-fold. Moreover, no cases of moderate or severe pancreatitis were observed in patients submitted to this intervention. Associated with nonsteroidal anti-inflammatory drugs, intensive hydration could constitute a new standard of care for patients undergoing ERCP.