Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-30 @ 4:16 PM
Study NCT ID:
NCT03811704
Status:
UNKNOWN
Last Update Posted:
2019-01-22
First Post:
2018-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2018-12-02', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver resection navigation success rate', 'timeFrame': 'intraoperative', 'description': 'Whether this technique successfully displayed the pre-resection line during the surgery were recorded.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complication rate', 'timeFrame': '3 months', 'description': 'The Postoperative complications were recorded.'}, {'measure': 'Operative outcomes', 'timeFrame': 'intraoperative', 'description': 'Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['three-dimensional reconstruction', 'fluorescence', 'indocyanine green', 'liver resection', 'navigation surgery'], 'conditions': ['Liver Resection']}, 'referencesModule': {'references': [{'pmid': '36648260', 'type': 'DERIVED', 'citation': 'Zhu W, Zeng X, Hu H, Xiang N, Zeng N, Wen S, Tian J, Yang J, Fang C. Perioperative and Disease-Free Survival Outcomes after Hepatectomy for Centrally Located Hepatocellular Carcinoma Guided by Augmented Reality and Indocyanine Green Fluorescence Imaging: A Single-Center Experience. J Am Coll Surg. 2023 Feb 1;236(2):328-337. doi: 10.1097/XCS.0000000000000472. Epub 2022 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the feasibility and efficacy of a novel real-time navigation way for laparoscope liver resection, which was fused images comprising 3D imaging and indocyanine green Fluorescence imaging (fusion IGFI).', 'detailedDescription': 'During liver resection, surgeons cannot completely view the intraparenchymal structure. Although a fluorescent imaging technique using indocyanine green has recently been developed for hepatobiliary surgery, limitations in its application for real-time navigation persist. A nove augmented reality surgery navigation system (ARSNS) can be combined with indocyanine green Fluorescence imaging to guide the surgery real-time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years≤ Age ≤70 years\n2. Compling with the diagnosis criteria of complex hepatic carcinoma.\n3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled\n4. Preoperative liver function is Child - Pugh grade A or B.\n5. The patients are volunteered for the study.\n\nExclusion Criteria:\n\n1. Patients with mental illness.\n2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)\n3. The patients refused to take part in the study.\n4. There are other co-existed malignant tumors.\n5. Benign liver diseases.\n6. Indocyanine green allergy"}, 'identificationModule': {'nctId': 'NCT03811704', 'briefTitle': 'Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging', 'orgStudyIdInfo': {'id': '201802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.', 'interventionNames': ['Device: Laparoscopic surgical navigation system', 'Drug: Indocyanine Green']}], 'interventions': [{'name': 'Laparoscopic surgical navigation system', 'type': 'DEVICE', 'description': 'We will use this navigation system to guide de liver resection.', 'armGroupLabels': ['Experimental group']}, {'name': 'Indocyanine Green', 'type': 'DRUG', 'description': 'ICG was administered 24 hours before the operation or intravenously after clamping the Glissonian sheaths flowing in the cancer-bearing hepatic segment, or directly into the portal branches supplying blood flow to the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510282', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chihua Fang, MD', 'role': 'CONTACT', 'email': 's_mountain@126.com', 'phone': '(+86)2062782568'}, {'name': 'Qingshan Chen, MM', 'role': 'CONTACT', 'email': 's_mountain@126.com', 'phone': '(+86)2062782568'}], 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Fang Chihua, M.D.;Ph.D', 'role': 'CONTACT', 'email': 'fangch_dr@126.com', 'phone': '+8613609700805'}], 'overallOfficials': [{'name': 'Chihua Fang, M.D.;Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'China, Guangdong Zhujiang Hospital of The Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}