Lactated Ringer's solution in combination with rectal indomethacin for prevention of post-ERCP pancreatitis and readmission: a prospective randomized, double-blinded, placebo-controlled trial.

BACKGROUND AND AIMS: Prospective data have shown the benefit of rectal indomethacin (IND) for preventing post-ERCP pancreatitis (PEP). A recent pilot study demonstrated a lower incidence of PEP after an 8-hour lactated Ringer's solution (LR) infusion. The aim of this study was to evaluate the efficacy of IND with or without bolus LR in patients at high-risk for PEP.

METHODS: In this randomized, double-blinded, placebo-controlled trial we assigned patients to standard normal saline solution (NS) + placebo, NS + IND, LR + placebo, or LR + IND. Each liter of fluid infusion was completed within 30 minutes. Patients were determined high-risk based established criterion and excluded if they had pancreatitis, contraindications to IND, or signs of volume overload. Our primary outcome was PEP, defined by standardized criterion. Our secondary outcomes were severe acute pancreatitis, localized adverse events, death, length of stay, and readmission.

RESULTS: Our sample consisted of 192 patients (48 per group) who completed follow-up at 24 hours and at 30 days post-ERCP. All patients had at least 1 high-risk criterion for PEP, and 56% had >1. PEP occurred in 3 patients (6%) in the LR + IND versus 10 (21%) in the NS + placebo group (P = .04). Readmission rates were lower in the LR + IND group (1 [2%]) versus the NS + placebo group (6 [13%]; P = .03). No differences were found between the other study groups. There was 1 case of severe pancreatitis (NS + IND) and 1 case of pseudocyst (LR + IND).

CONCLUSIONS: In patients at high risk for PEP, LR + IND reduced the incidence of PEP and readmission rates compared with NS + placebo. (Clinical trial registration number: NCT02641561.).