Tailored Hydration With Lactated Ringer's Solution for Postendoscopic Retrograde Cholangiopancreatography Pancreatitis Prevention: A Randomized Controlled Trial

Abstract

INTRODUCTION: Aggressive hydration using lactated Ringer's solution prevents postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Concerns of this strategy are large volume and lengthy hydration. Our study aimed to evaluate the efficacy of tailored aggressive hydration (TAH) for PEP prevention. METHODS: In this prospective, multicenter, double-blinded, randomized trial conducted across 3 tertiary Korean hospitals, patients who underwent ERCP for the first time were randomly assigned (1:1) to the tailored standard hydration (TSH) and TAH groups. The TSH group received 1.5 mL/kg/hr lactated Ringer's solution during and after ERCP, whereas the TAH group was administered a 20 mL/kg bolus post-ERCP and 3 mL/kg/hr during and after the procedure. Both groups were assessed for elevated serum amylase levels and pain 4–6 hours after ERCP. If both were absent, hydration was discontinued. If either was present, hydration was continued at the original rate until 8 hours. The primary end point was PEP development and was analyzed on an intention-to-treat analysis. RESULTS: A total of 344 patients were randomly assigned to treatment groups (171 to the TSH group and 172 to the TAH group). PEP was observed in 9.4% (16/171) in the TSH group and 3.5% (6/172) in the TAH group (relative risk 0.37, 95% confidence interval 0.15–0.93, P = 0.03). No difference was identified between the 2 groups in PEP severity (P = 0.80) and complications related to volume overload (P = 0.32). DISCUSSION: TAH according to the presence of abdominal pain or elevated serum amylase levels at 4–6 hours after ERCP is safe and prevents PEP development.