Background/aims
Aggressive peri- and post-endoscopic retrograde cholangiopancreatography (ERCP) intravenous hydration with lactated Ringer’s solution (LRS) is recommended for the prevention of post-ERCP pancreatitis (PEP). Concerns of this strategy are adverse events related to volume overload and long-time of hydration requiring admission. The aim of this study was to evaluate the efficacy of tailored hydration for the prevention of PEP.

Methods
This study was a prospective, multicenter, double-blinded, randomized controlled trial. Patients who underwent first-time ERCP were randomly assigned (1:1) to tailored standard hydration (TSH) group and tailored aggressive hydration (TAH) group. Patients received intravenous LRS either at a rate of 1.5 mL/kg/h during ERCP and for 4-6h after ERCP in the TSH group or at a rate of 3 mL/kg/h during ERCP, 20 mL/kg bolus after ERCP, and 3 mL/kg/h for 4-6h after ERCP in the TSH group. Both groups were assessed with serum amylase level and abdominal pain either 4h after ERCP with pancreatic stenting or 6h after ERCP without pancreatic stenting. If serum amylase level elevation or abdominal pain were both absent at 4-6h after ERCP, intravenous hydration was stopped, and if either one was present, intravenous hydration was continued at the original rate until 8h after ERCP. PEP was evaluated at 24h after ERCP. The primary endpoint was the development of PEP.

Results
A total of 343 patients were included in our analysis. Hydration was discontinued at 4-6h after ERCP in 51.5% (88/171) in TSH group and 51.2% (88/172) in TAH group (P = 0.96). PEP was developed in 9.4% (16/171) in the TSH group and 3.5% (6/172) in the TAH group, resulting in a relative risk (RR) of 0.37 (95% CI 0.15 – 0.93, P = 0.03) by intention-to-treat analysis. PEP was developed in 9.4% (16/171) in the TSH group and 3.5% (6/171) in the TAH group, resulting in a RR of 0.38 (95% CI 0.15 – 0.94, P = 0.03) by per-protocol analysis. There was no significant difference between the two groups in PEP severity (P = 0.80). There was no significant difference in the complications related to volume overload between the TSH and TAH groups: only one (0.6%) patient in the TSH group developed dyspnea, which recovered uneventfully.

Conclusions
Despite the individual decrease in fluid volume and hydration time, tailored aggressive hydration with LRS depending on the probability of PEP based on the presence of abdominal pain or elevated serum amylase levels at 4-6h after ERCP is a safe and effective method to prevent PEP.

Seung-Ok Lee

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