Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-28 @ 9:09 PM
Study NCT ID:
NCT01734720
Status:
COMPLETED
Last Update Posted:
2013-08-29
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Common Bile Duct Stones - Natural History and Interventions
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3828}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complications in relation to strategy for handling CBDS', 'timeFrame': '30 days post operative', 'description': 'Complications reported to the registry at 30 day follow up after surgery'}], 'secondaryOutcomes': [{'measure': 'complications in relation to stone size', 'timeFrame': '30 days post operative', 'description': 'Complications reported to the registry at 30 day follow up after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Common Bile Duct Stone']}, 'descriptionModule': {'briefSummary': 'The aims of this study were to\n\n1. investigate what measures were taken when common bile duct stones (CBDS) were found intraoperatively in Sweden during the period May 2005 to December 2009 by using data from this population-based nationwide registry, and\n2. analyze the outcome in terms of complications and success rates of bile duct clearance in relation to various stone sizes and interventions used. In order to further characterize the natural course of CBDS of various sizes, particular interest was focused on patients with positive findings where no peroperative measures to clear the bile ducts were taken or planned postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cholecystectomy with common bile duct stones found in peroperative cholangiogram', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* common bile duct stones\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01734720', 'briefTitle': 'Common Bile Duct Stones - Natural History and Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Common Bile Duct Stones - Natural History and Interventions : Data From the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangio Pancreatography (ERCP) (GallRiks)', 'orgStudyIdInfo': {'id': '2010/533-31/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'common bile duct stone', 'description': 'Patients undergoing cholecystectomy'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mats Möller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinsks Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ersta Hospital, Sweden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. consultant suregon, Ersta Hospital', 'investigatorFullName': 'Mats Möller', 'investigatorAffiliation': 'Karolinska Institutet'}}}}