Lactated Ringer's solution in combination with indomethacin for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A prospective, randomized trial.

BACKGROUND: Prospective data have shown the benefit of rectal indomethacin (IND) in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). Recent pilot studies demonstrated a lower incidence of PEP after an 8-hour lactated Ringer's solution (LR) infusion. AIM: To assess the efficacy of IND, with or without a bolus of LR, in patients at a high risk for PEP. METHODS: In this randomized, double-blinded controlled trial, we assigned patients to LR, IND, or LR + IND. Each liter of fluid infusion was completed within 30 minutes. Patients were determined to be high-risk based on established criteria 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: The study sample included 210 patients (70 per group) who accomplished follow-up at 24 hours and 30 days post-endoscopic retrograde cholangiopancreatography. All patients presented at least one high-risk factor for PEP, with 59% having more than one. PEP was observed in 23 patients (10,9%): Five patients (7%) in the LR + IND group vs twelve patients (17%) in the LR group (P = 0.04) and six patients (8%) in the IND group (P = 0.06). Readmission rates were reduced in the LR + IND group [2 (2%)] vs the LR group [7 (10%); P = 0.03]. No differences were seen among the other study groups. One case of severe acute pancreatitis was reported, with two cases in the LR group and one in the IND group. CONCLUSION: In high-risk patients for PEP, the combination of LR + IND decreased the incidence of PEP and readmission rates compared to LR or IND administered alone.