Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:46 AM
Study NCT ID:
NCT07417020
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Prophylactic Aggressive Hydration to Prevent Post-ERCP Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042883', 'term': 'Choledocholithiasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of post endoscopic retrograde cholangiopancreatography pancreatitis', 'timeFrame': '24 hours after endoscopic retrograde cholangiopancreatography, with confirmation based on a hospital stay of at least 2 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Frequency of isolated hyperamylasemia', 'timeFrame': '12 hours and 24 hours after endoscopic retrograde cholangiopancreatography', 'description': '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.'}, {'measure': 'Post procedure abdominal pain severity assessed by Visual Analog Scale', 'timeFrame': '4 hours, 12 hours, and 24 hours after endoscopic retrograde cholangiopancreatography', 'description': '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.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From day of endoscopic retrograde cholangiopancreatography until hospital discharge within 30 days', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic retrograde cholangiopancreatography', 'Post endoscopic retrograde cholangiopancreatography pancreatitis', 'Acute pancreatitis', 'Fluid therapy', "Lactated Ringer's solution", 'Aggressive intravenous hydration'], 'conditions': ['Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'Choledocholithiasis', 'Bile Duct Disorder', 'Biliary Obstruction']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 to 70 years.\n* Both males and females.\n* Patients undergoing their first Endoscopic Retrograde Cholangiopancreatography (ERCP) for choledocholithiasis, bile duct leak, or biliary obstruction.\n\nExclusion Criteria:\n\n* Patients who have previously undergone an ERCP, endoscopic sphincterectomy, or endoscopic papillary balloon dilatation.\n* Individuals with a known history of chronic pancreatitis, ongoing acute pancreatitis, or patients with gallstone pancreatitis or active cholangitis.\n* Patients with coagulopathy or those on anticoagulation therapy.\n* Pregnant or lactating women.\n* Substance abuse: Individuals with a history of alcohol or other substance abuse disorders.\n* Patients having hypernatremia or hyponatremia (Na \\<130 or Na \\>150 mEq/L) or Hyperkalemia (\\>5.1 mEq/dL).\n* Specific organ dysfunctions:\n* Patients with organ dysfunctions including cardiac insufficiency (New York Heart Association Class II or above), respiratory insufficiency (oxygen saturation \\<90%), renal insufficiency (creatinine clearance \\<40 mL/min), or liver dysfunction.\n* Clinical signs of fluid overload, specifically peripheral or pulmonary edema, and ongoing hypotension, including those with sepsis.\n* Patients undergoing sphincterotomy as it reduces the risk of pancreatitis.'}, 'identificationModule': {'nctId': 'NCT07417020', 'briefTitle': 'Role of Prophylactic Aggressive Hydration to Prevent Post-ERCP Pancreatitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lahore General Hospital'}, 'officialTitle': 'Role of Prophylactic Aggressive Hydration to Prevent Post-ERCP Pancreatitis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LahoreGeneralH14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Aggressive Hydration', 'description': "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.", 'interventionNames': ["Other: Aggressive intravenous hydration with lactated Ringer's solution"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Standard Hydration', 'description': "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.", 'interventionNames': ["Other: Standard intravenous hydration with lactated Ringer's solution"]}], 'interventions': [{'name': "Aggressive intravenous hydration with lactated Ringer's solution", 'type': 'OTHER', 'otherNames': ["Lactated Ringer's solution (aggressive protocol)"], 'description': "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", 'armGroupLabels': ['Group Aggressive Hydration']}, {'name': "Standard intravenous hydration with lactated Ringer's solution", 'type': 'OTHER', 'otherNames': ["Lactated Ringer's solution (standard protocol)"], 'description': "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", 'armGroupLabels': ['Group Standard Hydration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Lahore General Hospital, Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Ali Hassan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahore General Hospital, Lahore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahore General Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Irfan Jamil', 'investigatorAffiliation': 'Lahore General Hospital'}}}}