Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT05971069
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2023-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Enrolled patients will be divided into three groups according to the real time near-infrared fluorescence imaging during surgery.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging', 'timeFrame': 'Real time near-infrared fluorescence image will be obtained during the surgery.', 'description': "Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging.\n\nThe order of the algorithm is as follows:\n\nFirst, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed.\n\nAfter that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging.\n\nThe ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm."}], 'secondaryOutcomes': [{'measure': 'Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)', 'timeFrame': 'Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.', 'description': 'The elevated proprtion of the serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) compared to preoperative value will be calculated and compared by groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomach Neoplasm']}, 'descriptionModule': {'briefSummary': '" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.\n\nThere has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.\n\nThis prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery\n2. Patients aged between 20 to 80\n3. Patients with an ECOG 0 or 1\n4. Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery\n\nExclusion Criteria:\n\n1. Patients with abnormal liver function test befor surgery\n2. Patients who diagnosed liver cirrhosis or infectious liver disease\n3. Patients who underwent liver resection, or chemotherapy for gastric cancer\n4. Patients planned for combined liver resection or cholecystectomy during gastrectomy'}, 'identificationModule': {'nctId': 'NCT05971069', 'briefTitle': 'Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging: Prospective Study to Develop Decision Algorithm to Define the Preservation/Ligation of an Aberrant Left Hepatic Artery', 'orgStudyIdInfo': {'id': '3-2021-0376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1', 'description': 'Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery', 'interventionNames': ['Procedure: Group1']}, {'type': 'EXPERIMENTAL', 'label': 'Group2', 'description': 'Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery', 'interventionNames': ['Procedure: Group2']}, {'type': 'EXPERIMENTAL', 'label': 'Group3', 'description': 'No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery', 'interventionNames': ['Procedure: Group3']}], 'interventions': [{'name': 'Group1', 'type': 'PROCEDURE', 'description': 'Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery', 'armGroupLabels': ['Group1']}, {'name': 'Group2', 'type': 'PROCEDURE', 'description': 'Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery', 'armGroupLabels': ['Group2']}, {'name': 'Group3', 'type': 'PROCEDURE', 'description': 'No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery', 'armGroupLabels': ['Group3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'GangnamSeverance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'In Gyu Kwon', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}