Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07417020
Brief Summary:
Endoscopic Retrograde Cholangiopancreatography, also called ERCP, is a procedure used to diagnose and treat disorders of the bile ducts and pancreas. A common and potentially serious complication after ERCP is post ERCP pancreatitis, which is inflammation of the pancreas that can cause abdominal pain, raised pancreatic enzymes, prolonged hospital stay, and increased health care costs. Several preventive approaches have been evaluated, but an optimal, simple strategy that can be applied consistently in routine practice remains uncertain. This randomized controlled trial was evaluated whether giving a higher amount of intravenous lactated Ringer's solution around the time of ERCP reduces the risk of post ERCP pancreatitis compared with standard hydration. Adults aged 18 to 70 years undergoing their first ERCP for choledocholithiasis, bile duct leak, or biliary obstruction were randomly allocated to standard hydration or aggressive hydration. Standard hydration consists of lactated Ringer's solution at 1.5 mL/kg/hour during ERCP and for 8 hours after the procedure. Aggressive hydration consisted of lactated Ringer's solution at 3 mL/kg/hour during ERCP, followed immediately by a 20 mL/kg bolus and then 3 mL/kg/hour for 8 hours, with reduction to 1.5 mL/kg/hour if pain is absent after 8 hours. The primary hypothesis was that aggressive hydration is more effective than standard hydration in preventing post ERCP pancreatitis. Post procedure serum amylase was measured at 12 and 24 hours, and pain was assessed using a visual analog scale at 4, 12, and 24 hours. The main outcome is post ERCP pancreatitis, defined by new or worsening abdominal pain with enzyme elevation more than three times the upper limit of normal at 24 hours and a hospital stay of at least 2 days. Secondary outcomes include isolated hyperamylasemia, post procedure pain, and length of hospital stay. The study was conducted over 12 months at the Department of Gastroenterology, Lahore General Hospital, Lahore, with a total sample size of 126 participants.
Study:
NCT07417020
Study Brief:
Protocol Section:
NCT07417020