Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05926856
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2023-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Quality Fluorescent Cholangiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-12', 'releaseDate': '2024-01-28'}], 'estimatedResultsFirstSubmitDate': '2024-01-28'}}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2023-06-29', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Common bile duct-to-liver fluorescence intensity ratio', 'timeFrame': 'Intraoperative (The beginning of the surgery)', 'description': 'Common bile duct-to-liver fluorescence intensity ratio'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['icg', 'fluorescent cholangiograph'], 'conditions': ['Extrahepatic Biliary Tree Injury']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography.', 'detailedDescription': 'Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green（ICG） still lacks standardization, and not every visualization of the extrahepatic biliary tract is satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can achieve the best fluorescence imaging of the biliary tract, but some research groups have suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the satisfaction of fluorescence imaging. However, no study compares the quality of biliary fluorescence imaging between the two injection protocols. This study will compare the fluorescence imaging effects of the two schemes to obtain the best injection scheme at present and standardize the use of icg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient has indications for cholecystectomy and requires laparoscopic treatment；\n2. No biliary obstruction or cholestasis was found during preoperative examination；3.Volunteer to participate in this clinical trial and sign written informed consent.\n\nExclusion Criteria:\n\n1. Patients who require emergency surgical treatment；\n2. Patients with malignant tumors of the biliary tract；\n3. Patients with a history of abdominal surgery；\n4. Patients who are allergic to indocyanine green or iodine contrast agents；5.Patients participating in one or more other clinical trials simultaneously；\n\n6.Patients who have received medication that affects bile excretion within 2 weeks before surgery； 7.Other situations that have been judged unsuitable for inclusion by researchers.'}, 'identificationModule': {'nctId': 'NCT05926856', 'acronym': 'HQFC', 'briefTitle': 'High Quality Fluorescent Cholangiography', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Comparison of the Fluorescent Visualization of the Extrahepatic Biliary Tract Between Two Injection Protocols', 'orgStudyIdInfo': {'id': '20230420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 day before surgery', 'description': '0.25mg/kg Indocyanine Green will be administered 1 day before surgery', 'interventionNames': ['Drug: Indocyanine green']}, {'type': 'EXPERIMENTAL', 'label': '45 min before surgery', 'description': '0.05mg Indocyanine Green will be administered 45minutes before surgery', 'interventionNames': ['Drug: Indocyanine green']}], 'interventions': [{'name': 'Indocyanine green', 'type': 'DRUG', 'description': 'Indocyanine Green 25mg kit for injection', 'armGroupLabels': ['1 day before surgery', '45 min before surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jian Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhujiang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chihua Fang,MD', 'investigatorAffiliation': 'Zhujiang Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-01-28', 'type': 'RELEASE'}, {'date': '2024-07-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chihua Fang,MD, Professor, Zhujiang Hospital'}}}}