Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT00505128
Status:
COMPLETED
Last Update Posted:
2011-05-09
First Post:
2007-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016717', 'term': 'Sphincterotomy, Endoscopic'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D000074432', 'term': 'Sphincterotomy'}, {'id': 'D000074433', 'term': 'Myotomy'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-06', 'studyFirstSubmitDate': '2007-07-20', 'studyFirstSubmitQcDate': '2007-07-20', 'lastUpdatePostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients cured or consolidated as a function of time', 'timeFrame': 'during 12 months'}], 'secondaryOutcomes': [{'measure': 'overall morbidity', 'timeFrame': 'during the 36 months'}, {'measure': 'overall mortality', 'timeFrame': 'during the 36 months'}, {'measure': 'endoscopic procedure-related morbidity and mortality', 'timeFrame': 'during the 12months'}, {'measure': 'LOS', 'timeFrame': 'during the 12 months'}, {'measure': 'morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)', 'timeFrame': 'during the 12 months'}, {'measure': 'economic data', 'timeFrame': 'during the 36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biliary pancreatitis', 'Bile duct stones', 'EUS Endoscopic UltraSonography', 'Endoscopic sphincterotomy', 'ERCP'], 'conditions': ['Biliary Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.', 'detailedDescription': 'Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.\n\nMain objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.\n\nProspective multicenter randomized controlled study with direct patient benefit'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous medical examination\n* Age over 18\n* Acute biliary pancreatitis\n* Timespan between onset of symptoms and randomization \\<72h\n* No involvement in another clinical study\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Non biliary pancreatitis\n* Age \\< 18\n* Timespan between onset of symptoms and randomization \\>72h\n* No follow-up possible beyond 3 months after inclusion\n* Ongoing pregnancy\n* No informed consent\n* No health insurance affiliation\n* Involvement in another clinical study\n* Incapacity to understand subject information\n* Counter indication of MRI examination if echo-endoscopy is not available'}, 'identificationModule': {'nctId': 'NCT00505128', 'acronym': 'EEPAB', 'briefTitle': 'Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'P051054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography', 'interventionNames': ['Procedure: Endoscopic sphincterotomy']}], 'interventions': [{'name': 'Endoscopic sphincterotomy', 'type': 'PROCEDURE', 'otherNames': ['procedure'], 'description': 'procedure', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Frederic PRAT, MD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cecile jourdain', 'oldOrganization': 'Department of Clinical Research of developpement'}}}}