Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-30 @ 10:53 PM
Study NCT ID:
NCT01189734
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2010-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2010-08-26', 'studyFirstSubmitDate': '2010-08-25', 'studyFirstSubmitQcDate': '2010-08-26', 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success/failure of common bile duct removal'}], 'secondaryOutcomes': [{'measure': 'Surgical time'}]}, 'conditionsModule': {'keywords': ['common bile duct stones', 'laparoscopic common bile duct exploration', 'intraoperative ercp', 'Preoperatively diagnosed common bile duct stones'], 'conditions': ['Common Bile Duct Gallstones']}, 'descriptionModule': {'briefSummary': 'Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '12 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preoperatively diagnosed common bile duct stones\n\nExclusion Criteria:\n\n* liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy'}, 'identificationModule': {'nctId': 'NCT01189734', 'briefTitle': 'Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'orgStudyIdInfo': {'id': 'LCBDEIOES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'laparoscopic common bile duct exploration', 'interventionNames': ['Procedure: laparoscopic common bile duct exploration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic cholecystectomy with intraoperative ES', 'interventionNames': ['Procedure: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy']}], 'interventions': [{'name': 'laparoscopic common bile duct exploration', 'type': 'PROCEDURE', 'armGroupLabels': ['laparoscopic common bile duct exploration']}, {'name': 'laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy', 'type': 'PROCEDURE', 'armGroupLabels': ['laparoscopic cholecystectomy with intraoperative ES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Gastroenterology Surgical Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}}}}