Aggressive hydration with Lactated Ringer’s solution as the prophylactic intervention for postendoscopic retrograde cholangiopancreatography pancreatitis: A randomized controlled double-blind clinical trial

Background: Pancreatitis is a serious complication of endoscopic retrograde cholangiopancreatography (ERCP) and may cause significant morbidity and even death. There is no effective prophylactic intervention for patients with average risk yet. This study aims to investigate preventive effect of aggressive hydration for post-ERCP pancreatitis. Materials and Methods: In a double-blind controlled setting, 150 patient were randomly assigned to receive either aggressive hydration with lactated Ringer’s solution (3 mL/ kg/h during ERCP, followed by a 20 mL/kg bolus and 3 mL/kg/h for 8 h after the procedure, n = 75) or standard amount of hydration (1.5 mL/kg/h during and for 8 h after ERCP, n = 75). Patients were observed for volume overload as well as pancreatic pain and serum levels of amylase at baseline and 2, 8, and 24 h after ERCP. Post-ERCP pancreatitis was defined as hyperamylasemia (level of amylase >300) and pancreatic pain during the 24 h follow-up. Hyperamylasemia and pancreatic pain were the secondary end points. Results: Mean age of the patients was 50.8 ± 13.5 years. Most of the patients were female (66%). Pancreatitis developed in 21 patients, including 22.7% of patients receiving standard hydration and 5.3% patients receiving aggressive hydration (P = 0.002). Hyperamylasemia was detected in 44.0% of patients receiving standard hydration and 22.7% of patients aggressive hydration (P = 0.006). The pancreatic pain was reported by 5.3% of patients receiving aggressive hydration and 37.3% of patients receiving standard hydration (P ≤ 0.005). Conclusion: Aggressive hydration with lactated Ringer’s solution may effectively prevent post-ERCP pancreatitis as well as hyperamylasemia and pancreatic pain in patients with average risk.