An interventional study of Aggressive intravenous hydration with lactated Ringer's solution and Standard intravenous hydration with lactated Ringer's solution in Endoscopic Retrograde Cholangiopancreatography (ERCP), Choledocholithiasis and Bile Duct Disorder, sponsored by Lahore General Hospital. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Lahore General Hospital · Not applicable, Interventional, and Prevention
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.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 126 is above the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Lahore General Hospital is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Received aggressive intravenous hydration with lactated Ringer's solution during endoscopic retrograde cholangiopancreatography and for the subsequent 8 hours post procedure, according to the study protocol.
Other: Aggressive intravenous hydration with lactated Ringer's solution
Received standard intravenous hydration with lactated Ringer's solution during endoscopic retrograde cholangiopancreatography and for the subsequent 8 hours post procedure, according to standard care protocol.
Other: Standard intravenous hydration with lactated Ringer's solution
Lactated Ringer's solution at 3 mL/kg/hour during endoscopic retrograde cholangiopancreatography. Immediately after the procedure, 20 mL/kg bolus of lactated Ringer's solution. Then 3 mL/kg/hour for 8 hours. If no pain after 8 hours, rate reduced to 1.5 mL/kg/hour. Hydration discontinued once the patient can comfortably tolerate a regular diet
Also known as: Lactated Ringer's solution (aggressive protocol)
Lactated Ringer's solution at 1.5 mL/kg/hour during endoscopic retrograde cholangiopancreatography. Continued at 1.5 mL/kg/hour for 8 hours after the procedure. If post endoscopic retrograde cholangiopancreatography pancreatitis develops, a 20 mL/kg bolus may be administered, followed by 3 mL/kg/hour, as per management protocol
Also known as: Lactated Ringer's solution (standard protocol)
Incidence of post endoscopic retrograde cholangiopancreatography pancreatitis
Post endoscopic retrograde cholangiopancreatography pancreatitis was diagnosed when new or worsening abdominal pain occurs after the procedure, with pancreatic enzyme elevation more than three times the upper limit of normal at 24 hours, and the clinical course requires hospital admission for at least 2 days.
Time frame: 24 hours after endoscopic retrograde cholangiopancreatography, with confirmation based on a hospital stay of at least 2 days
Frequency of isolated hyperamylasemia
Isolated hyperamylasemia was defined as serum amylase elevation more than three times the upper limit of normal during the first 24 hours after the procedure, without meeting criteria for post endoscopic retrograde cholangiopancreatography pancreatitis.
Time frame: 12 hours and 24 hours after endoscopic retrograde cholangiopancreatography
Post procedure abdominal pain severity assessed by Visual Analog Scale
Abdominal pain was assessed using a 0 to 10 Visual Analog Scale. Pancreatic pain will be defined as development of pain, or an increase in pain, of at least 3 points compared with pre procedure pain score, persisting during follow up.
Time frame: 4 hours, 12 hours, and 24 hours after endoscopic retrograde cholangiopancreatography
Length of hospital stay
Length of hospital stay was measured as the number of days from the day of endoscopic retrograde cholangiopancreatography to the day of discharge within 30 days.
Time frame: From day of endoscopic retrograde cholangiopancreatography until hospital discharge within 30 days
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Lahore General Hospital