Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT05506020
Status:
COMPLETED
Last Update Posted:
2022-08-18
First Post:
2022-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biliary complications', 'timeFrame': 'two months after operation', 'description': 'bile leakage and biliary stenosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Living Donor Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during laparoscopic left lateral sectionectomy (LLLS) on the occurrence of biliary complications in both donors and recipients in living donor liver transplantation (LDLT) and to explore the optimal dose and injection time of ICG.', 'detailedDescription': 'This was a retrospective cohort study. The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during LLLS on the occurrence of biliary complications in both donors and recipients. The optimal dose and injection time of ICG were also investigated. From October 2016 to May 2022, the clinical data of 85 donors who underwent LLLS and relevant recipients in the Department of General Surgery of Huashan Hospital were retrospectively analyzed. According to whether ICG fluorescence cholangiography was used, they were divided into a non-ICG group (n=46) and an ICG group (n=39). Biliary complications were observed and the optimal dose and injection time of ICG were explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. From October 2016 to May 2022, donors and their corresponding recipients underwent laparoscopic donor liver acquisition surgery in the general surgery department of Huashan Hospital.\n2. Donor age ≥ 18 years old, regardless of gender; The receptor is the corresponding receptor of the donor, and the age and sex of the receptor are unlimited.\n3. The medical history is complete, which can meet the requirements of this study.\n4. Volunteer to participate in this study.\n\nExclusion Criteria:\n\n1. The medical history is incomplete, which cannot meet the requirements of this study.\n2. The donor or recipient expressly refused to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05506020', 'briefTitle': 'Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Retrospective Study on the Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy', 'orgStudyIdInfo': {'id': 'Huashan009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICG group', 'description': 'indocyanine green (ICG) fluorescence cholangiography', 'interventionNames': ['Procedure: indocyanine green (ICG) fluorescence cholangiography']}, {'type': 'NO_INTERVENTION', 'label': 'non ICG group', 'description': 'no intervention'}], 'interventions': [{'name': 'indocyanine green (ICG) fluorescence cholangiography', 'type': 'PROCEDURE', 'description': 'indocyanine green (ICG) fluorescence cholangiography during operation', 'armGroupLabels': ['ICG group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lunxiu Qin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of general surgery, Huashan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the department of general surgery, Huashan Hospital', 'investigatorFullName': 'Lunxiu Qin', 'investigatorAffiliation': 'Fudan University'}}}}