Jun-Ho Choi1, Hong Ja Kim2, Byung Uk Lee3, Tae Hyeon Kim4, Il Han Song2. 1. Department of Internal Medicine, Dankook University College of Medicine, Dankook University Hospital, Cheonan, Korea. Electronic address: mdcjh78@gmail.com. 2. Department of Internal Medicine, Dankook University College of Medicine, Dankook University Hospital, Cheonan, Korea. 3. Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan University Hospital, Ulsan, Korea. 4. Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea.
Abstract
BACKGROUND & AIMS:Vigorous intravenous fluid resuscitation (IVFR) was reported to reduce post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in a pilot study. We performed a randomized, double-blind controlled trial to establish whether periprocedural vigorous IVFR reduces the risk of post-ERCP pancreatitis. METHODS: A total of 510 patients with native papilla at 3 tertiary referral centers in Korea were randomly assigned (1:1) to groups given vigorous IVFR (lactated Ringer's solution in an initial bolus of 10 mL/kg before the procedure, 3 mL/kg/h during the procedure, for 8 hours after the procedure, and a post-procedure bolus of 10 mL/kg) or a standard IVFR (lactated Ringer's solution at 1.5 mL/kg/h during and for 8 hours after the procedure). The primary end point of the study was the development of post-ERCP pancreatitis, and the secondary end point was severity of pancreatitis, hyperamylasemia, and fluid overload. RESULTS: The main indications for ERCP were choledocholithiasis (58%) and malignant biliary stricture (27%). Post-ERCP pancreatitis developed in 11 patients in the vigorous IVFR group (4.3%) and 25 patients in the standard IVFR group (9.8%) (relative risk, 0.41; 95% CI, 0.20-0.86; P = .016). Moderate or severe acute pancreatitis occurred in a significantly smaller proportion of patients in the vigorous IVFR group (0.4%) than in the standard IVFR group (2.0%; P = .040). One patient in the vigorous IVFR group developed peripheral edema. CONCLUSIONS: In a double-blind, randomized controlled trial, we found vigorous periprocedural intravenous hydration with lactated Ringer's solution to reduce the incidence and severity of post-ERCP pancreatitis in average-risk and high-risk cases. IVFR is not associated with increased adverse events. ClinicalTrials.gov number: NCT02308891.
RCT Entities:
BACKGROUND & AIMS: Vigorous intravenous fluid resuscitation (IVFR) was reported to reduce post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in a pilot study. We performed a randomized, double-blind controlled trial to establish whether periprocedural vigorous IVFR reduces the risk of post-ERCP pancreatitis. METHODS: A total of 510 patients with native papilla at 3 tertiary referral centers in Korea were randomly assigned (1:1) to groups given vigorous IVFR (lactated Ringer's solution in an initial bolus of 10 mL/kg before the procedure, 3 mL/kg/h during the procedure, for 8 hours after the procedure, and a post-procedure bolus of 10 mL/kg) or a standard IVFR (lactated Ringer's solution at 1.5 mL/kg/h during and for 8 hours after the procedure). The primary end point of the study was the development of post-ERCP pancreatitis, and the secondary end point was severity of pancreatitis, hyperamylasemia, and fluid overload. RESULTS: The main indications for ERCP were choledocholithiasis (58%) and malignant biliary stricture (27%). Post-ERCP pancreatitis developed in 11 patients in the vigorous IVFR group (4.3%) and 25 patients in the standard IVFR group (9.8%) (relative risk, 0.41; 95% CI, 0.20-0.86; P = .016). Moderate or severe acute pancreatitis occurred in a significantly smaller proportion of patients in the vigorous IVFR group (0.4%) than in the standard IVFR group (2.0%; P = .040). One patient in the vigorous IVFR group developed peripheral edema. CONCLUSIONS: In a double-blind, randomized controlled trial, we found vigorous periprocedural intravenous hydration with lactated Ringer's solution to reduce the incidence and severity of post-ERCP pancreatitis in average-risk and high-risk cases. IVFR is not associated with increased adverse events. ClinicalTrials.gov number: NCT02308891.
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