James Buxbaum1, Arthur Yan1, Kelvin Yeh1, Christianne Lane1, Nancy Nguyen1, Loren Laine2. 1. Division of Gastroenterology, University of Southern California, Los Angeles, California. 2. Yale University School of Medicine, New Haven, Connecticut and VA Connecticut Healthcare System, West Haven, Connecticut. Electronic address: loren.laine@yale.edu.
Abstract
BACKGROUND & AIMS: Pancreatitis is the most common serious complication of endoscopic retrograde cholangiopancreatography (ERCP). We performed a pilot study to determine whether aggressive periprocedural hydration with lactated Ringer's solution reduces the incidence of pancreatitis after ERCP. METHODS:Patients who underwent first-time ERCP were randomly assigned to groups (2:1) that received aggressive hydration with lactated Ringer's solution (3 mL/kg/h during the procedure, a 20-mL/kg bolus after the procedure, and 3 mL/kg/h for 8 hours after the procedure, n = 39) or standard hydration with the same solution (1.5 mL/kg/h during and for 8 hours after procedure, n = 23). Serum levels of amylase, visual analogue pain scores (scale of 0-10), and volume overload were assessed at baseline and 2, 8, and 24 hours after ERCP. The primary end point, post-ERCP pancreatitis, was defined as hyperamylasemia (level of amylase >3 times the upper limit of normal) and increased epigastric pain (≥3 points on visual analogue scale) persisting for ≥24 hours after the procedure. Secondary end points included hyperamylasemia, increased pain, and volume overload. RESULTS: None of the patients who received aggressive hydration developed post-ERCP pancreatitis, compared with 17% of patients who received standard hydration (P = .016). Hyperamylasemia developed in 23% of patients who received aggressive hydration vs 39% of those who received standard hydration (P = .116, nonsignificant); increased epigastric pain developed in 8% of patients who received aggressive hydration vs 22% of those who received standard hydration (P = .146, nonsignificant). No patients had evidence of volume overload. CONCLUSIONS: On the basis of a pilot study, aggressive intravenous hydration with lactated Ringer's solution appears to reduce the development of post-ERCP pancreatitis and is not associated with volume overload. ClinicalTrials.gov, Number: NCT 01758549.
RCT Entities:
BACKGROUND & AIMS:Pancreatitis is the most common serious complication of endoscopic retrograde cholangiopancreatography (ERCP). We performed a pilot study to determine whether aggressive periprocedural hydration with lactated Ringer's solution reduces the incidence of pancreatitis after ERCP. METHODS:Patients who underwent first-time ERCP were randomly assigned to groups (2:1) that received aggressive hydration with lactated Ringer's solution (3 mL/kg/h during the procedure, a 20-mL/kg bolus after the procedure, and 3 mL/kg/h for 8 hours after the procedure, n = 39) or standard hydration with the same solution (1.5 mL/kg/h during and for 8 hours after procedure, n = 23). Serum levels of amylase, visual analogue pain scores (scale of 0-10), and volume overload were assessed at baseline and 2, 8, and 24 hours after ERCP. The primary end point, post-ERCP pancreatitis, was defined as hyperamylasemia (level of amylase >3 times the upper limit of normal) and increased epigastric pain (≥3 points on visual analogue scale) persisting for ≥24 hours after the procedure. Secondary end points included hyperamylasemia, increased pain, and volume overload. RESULTS: None of the patients who received aggressive hydration developed post-ERCP pancreatitis, compared with 17% of patients who received standard hydration (P = .016). Hyperamylasemia developed in 23% of patients who received aggressive hydration vs 39% of those who received standard hydration (P = .116, nonsignificant); increased epigastric pain developed in 8% of patients who received aggressive hydration vs 22% of those who received standard hydration (P = .146, nonsignificant). No patients had evidence of volume overload. CONCLUSIONS: On the basis of a pilot study, aggressive intravenous hydration with lactated Ringer's solution appears to reduce the development of post-ERCP pancreatitis and is not associated with volume overload. ClinicalTrials.gov, Number: NCT 01758549.
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