Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-01 @ 3:27 PM
Study NCT ID:
NCT04145869
Status:
WITHDRAWN
Last Update Posted:
2024-02-28
First Post:
2019-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescent Cholangiography During Acute Cholecystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visualizationrate', 'timeFrame': '1 hour', 'description': 'Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.'}], 'secondaryOutcomes': [{'measure': 'Visualizationrate', 'timeFrame': '1 hour', 'description': 'Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct'}, {'measure': 'Bile duct stones', 'timeFrame': '1 hour', 'description': 'Percentage of patients with visualization of bile duct stones'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorescence', 'Cholangriography', 'Cholecystectomy'], 'conditions': ['Acute Cholecystitis']}, 'descriptionModule': {'briefSummary': 'This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window)\n\nExclusion criteria\n\n* Laparoscopic operation converted to open operation prior to completed fluorescent and X-ray cholangiography\n* Allergy towards iodine, Iohexol or indocyanine green\n* Legally incompetent (any reason)\n* Cholangitis (as defined above)15\n* Withdrawal of inclusion consent at any time'}, 'identificationModule': {'nctId': 'NCT04145869', 'briefTitle': 'Fluorescent Cholangiography During Acute Cholecystitis', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis', 'orgStudyIdInfo': {'id': 'IFC3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluorescent cholangiography', 'description': 'Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green', 'interventionNames': ['Procedure: Cholangiography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'X-ray cholangiography', 'description': 'Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol', 'interventionNames': ['Procedure: Cholangiography']}], 'interventions': [{'name': 'Cholangiography', 'type': 'PROCEDURE', 'description': 'All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography', 'armGroupLabels': ['Fluorescent cholangiography', 'X-ray cholangiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'state': 'Danmark', 'country': 'Denmark', 'facility': 'Northzealand Hospiral Hillerød', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '2650', 'city': 'Hvidovre', 'state': 'Danmark', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Zealand University Hospital Køge', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, {'name': 'Zealand University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Lars Lang Lehrskov', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}