Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2026-03-10 @ 10:38 AM
Study NCT ID:
NCT06865612
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Analysis of Preoperative Liver Volumetry in Living Donor Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of preoperative estimated graft volume (EGV) compared to actual graft weight (AGW)', 'timeFrame': 'From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)', 'description': 'The accuracy of preoperative donor CT liver volumetry will be assessed by comparing estimated graft volume (EGV) obtained from three methods (automated, semi-automated, manual) with the actual graft weight (AGW) measured intraoperatively. The error ratio between EGV and AGW will be calculated for each method.'}], 'secondaryOutcomes': [{'measure': 'Determination of the optimal dry weight correction factor for each volumetry method', 'timeFrame': 'From preoperative CT scan (1-2 months before transplantation) to intraoperative measurement (day of transplantation)', 'description': 'The study aims to determine the optimal dry weight correction factor by minimizing the discrepancy between EGV and AGW.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Living Donor Liver Transplantation', 'Liver Failure']}, 'descriptionModule': {'briefSummary': 'Accurate preoperative graft volume assessment is crucial for successful living donor liver transplantation (LDLT). Although manual and automated computed tomography (CT) volume measurement methods using various volumetric tools are widely used, their accuracy remains uncertain. This study aimed to determine the optimal dry weight correction factor for each method to enhance the prediction of actual graft weight (AGW) and compare the accuracy of different methods.', 'detailedDescription': 'This study is a retrospective diagnostic accuracy study comparing three liver volumetry methods using preoperative donor CT scans in LDLT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes patients who underwent hepatectomy for living donor liver transplantation performed at Chungnam National University Hospital. Data will be retrospectively reviewed to compare preoperative estimated graft volume (EGV) to actual graft weight (AGW).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent hepatectomy for living donor liver transplantation performed by the Department of Surgery at Chungnam National University Hospital under the supervision of the principal investigator.\n\nExclusion Criteria:\n\n* Patients deemed unsuitable for participation in this clinical study by the investigator.'}, 'identificationModule': {'nctId': 'NCT06865612', 'briefTitle': 'A Comparative Analysis of Preoperative Liver Volumetry in Living Donor Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Chungnam National University Hospital'}, 'officialTitle': "Optimizing Accuracy: a Comparative Analysis of Preoperative Liver Volumetry in Living Donor Liver Transplantation from a Surgeon's Perspective", 'orgStudyIdInfo': {'id': '2024-05-025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Donors', 'description': 'Patients who received hepatectomy for the living donor liver transplantation.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will not be shared publicly due to the retrospective nature of the study and privacy protection concerns.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chungnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}