Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Hydration is considered a mainstay of treatment for acute pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP pancreatitis.~Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration (treatment arm) or standard hydration (standard arm). Randomization will be performed in a double blinded fashion using computer-generated random numbers.~Treatment arm (vigorous hydration arm);~Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP~Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and continued for 8 hours.~At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over 1 hour~Standard arm (standard hydration arm);~- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP.~The primary endpoint is development of post-ERCP pancreatitis, which define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).~The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of pancreatitis, and fluid overload.~Serum amylase levels are measured at baseline, and at 8 hours and 18-24 hours, 48 hours after the procedure.~Investigators recorded the details of the maneuvers performed, including:~the total time of the procedure,~the number of attempts at cannulation,~the number of pancreatic duct cannulation,~the final diagnosis by ERCP,~whether a sphincterotomy, a needle-knife papillotomy, or stent placement~endoscopic papillary balloon dilation,~common bile duct (C) tissue sampling (biopsy, brush, cytology),~common bile duct-intraductal ultrasonography (C-IDUS),~Serum amylase is determined 8, 18~24, and 48 hours after ERCP.~If the 12-hours serum amylase level was > 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.~Acute pancreatitis is defined as serum amylase > 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.~Statistical analysis:~Randomization was done by the GI nurse, concealed envelop~Data were summarized by descriptive statistics.~The Chi square was used to compare categorical patient data.~The Student's t test was used to compare continuous variables.~Two-tailed P < 0.05 was considered to indicate significance.
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Hydration is considered a mainstay of treatment for acute pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP pancreatitis.~Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited.~Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration (treatment arm) or standard hydration (standard arm). Randomization will be performed in a double blinded fashion using computer-generated random numbers.~Treatment arm (vigorous hydration arm);~Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP~Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and continued for 8 hours.~At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over 1hour Standard arm (standard hydration arm);~Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP.~The primary endpoint was development of post-ERCP pancreatitis, which define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).~The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of pancreatitis, and fluid overload.