Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-21 @ 12:25 AM
Study NCT ID:
NCT02136095
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2014-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promising Initial Experience With Intra-operative Fluorescent Cholangiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2014-05-07', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time expenditure of IFC with concomitant angiography.', 'timeFrame': 'Four months', 'description': 'Intra-operative fluorescent-imaging-mode-time was registered by a study-nurse during the operations (performed between september and december 2013)'}], 'secondaryOutcomes': [{'measure': 'Success-rate of the IFC-procedures.', 'timeFrame': 'Four months', 'description': 'The operating surgeon completed a structured questionnaire immediately after each operation regarding anatomical identification by IFC (visible cystic duct, -common bile duct, -common hepatic duct, -right and left hepatic ducts, -cystic artery, -aberrant bile ducts, and/or other abnormalities).\n\nSuccessful IFC was defined as exposure of the junction between the cystic duct, common bile duct and common hepatic duct by IFC. Success-full fluorescent angiography was defined as adequate visualisation of the cystic artery within Calot´s triangle by the method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fluorescent cholangiography', 'Laparoscopic cholecystectomy'], 'conditions': ['Gall Stone Disease']}, 'referencesModule': {'references': [{'pmid': '25162446', 'type': 'DERIVED', 'citation': 'Larsen SS, Schulze S, Bisgaard T. Non-radiographic intraoperative fluorescent cholangiography is feasible. Dan Med J. 2014 Aug;61(8):A4891.'}]}, 'descriptionModule': {'briefSummary': 'Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is a recently developed method for non-invasive visualisation of the relevant anatomy during laparoscopic cholecystectomy. The objective of this study was to assess the time required by routine-use of IFC and to evaluate success-rate of the procedures.\n\nMethods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the same surgeon were consecutively enrolled. A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative time-registration and exposure of predefined anatomical structures were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age \\> 18 years\n* Scheduled for acute- or elective laparoscopic cholecystectomy\n* Informed consent\n\nExclusion criteria:\n\n* Known iodine-hypersensitivity\n* Liver- or renal insufficiency\n* Known thyrotoxicosis\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT02136095', 'briefTitle': 'Promising Initial Experience With Intra-operative Fluorescent Cholangiography', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Promising Initial Experience With Intra-operative Fluorescent Cholangiography', 'orgStudyIdInfo': {'id': 'IFC_Feasibility_study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IFC-group', 'description': 'The investigators included patients undergoing laparoscopic cholecystectomy by a single surgeon between September and December 2013 at a single centre university department with unrestricted referral of patients. The included patients represented all patients undergoing laparoscopic cholecystectomy by one surgeon during the study period. All patients underwent intra-operative fluorescent cholangiography (IFC) with concomitant angiography, according to a standardized protocol, during their laparoscopic cholecystectomy.', 'interventionNames': ['Procedure: Intraoperative fluorescent cholangiography (IFC)']}], 'interventions': [{'name': 'Intraoperative fluorescent cholangiography (IFC)', 'type': 'PROCEDURE', 'description': 'A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.', 'armGroupLabels': ['IFC-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2650', 'city': 'Hvidovre', 'state': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Søren Larsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gastroenheden, Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Søren S. Larsen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}