Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-04 @ 4:05 AM
Study NCT ID:
NCT05132192
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2021-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017131', 'term': 'Thrombectomy'}], 'ancestors': [{'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Time (days) from post transplant day1 to post transplant1 year', 'description': 'Posttransplant survival time'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'From posttransplant day1 to post-transplant 30th day', 'description': 'Highest grade of complication after LDLT according to Dindo-Clavien Classification'}, {'measure': 'Flow', 'timeFrame': 'Intraoperatively twice: before recipient hepatectomy (portal flow of diseased liver ) and at the end of transplantation procedure', 'description': 'Intraoperative portal flow measurements (ml/min) of diseased liver and transplanted liver with Doppler flowmeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver transplantation', 'Portal vein thrombosis', 'Thrombectomy', 'Doppler flowmeter'], 'conditions': ['Portal Vein Thrombosis', 'Liver Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '28834305', 'type': 'BACKGROUND', 'citation': 'Conzen KD, Pomfret EA. Liver transplant in patients with portal vein thrombosis: Medical and surgical requirements. Liver Transpl. 2017 Oct;23(S1):S59-S63. doi: 10.1002/lt.24856. No abstract available.'}, {'pmid': '10830225', 'type': 'BACKGROUND', 'citation': 'Yerdel MA, Gunson B, Mirza D, Karayalcin K, Olliff S, Buckels J, Mayer D, McMaster P, Pirenne J. Portal vein thrombosis in adults undergoing liver transplantation: risk factors, screening, management, and outcome. Transplantation. 2000 May 15;69(9):1873-81. doi: 10.1097/00007890-200005150-00023.'}, {'pmid': '21183851', 'type': 'BACKGROUND', 'citation': 'Ravaioli M, Zanello M, Grazi GL, Ercolani G, Cescon M, Del Gaudio M, Cucchetti A, Pinna AD. Portal vein thrombosis and liver transplantation: evolution during 10 years of experience at the University of Bologna. Ann Surg. 2011 Feb;253(2):378-84. doi: 10.1097/SLA.0b013e318206818b.'}, {'pmid': '30230053', 'type': 'BACKGROUND', 'citation': 'Zanetto A, Rodriguez-Kastro KI, Germani G, Ferrarese A, Cillo U, Burra P, Senzolo M. Mortality in liver transplant recipients with portal vein thrombosis - an updated meta-analysis. Transpl Int. 2018 Dec;31(12):1318-1329. doi: 10.1111/tri.13353. Epub 2018 Oct 23.'}, {'pmid': '25822434', 'type': 'BACKGROUND', 'citation': 'Qi X, Dai J, Jia J, Ren W, Yang M, Li H, Fan D, Guo X. Association between portal vein thrombosis and survival of liver transplant recipients: a systematic review and meta-analysis of observational studies. J Gastrointestin Liver Dis. 2015 Mar;24(1):51-9, 4 p following 59. doi: 10.15403/jgld.2014.1121.qix.'}, {'pmid': '24299686', 'type': 'BACKGROUND', 'citation': 'Hibi T, Nishida S, Levi DM, Selvaggi G, Tekin A, Fan J, Ruiz P, Tzakis AG. When and why portal vein thrombosis matters in liver transplantation: a critical audit of 174 cases. Ann Surg. 2014 Apr;259(4):760-6. doi: 10.1097/SLA.0000000000000252.'}]}, 'descriptionModule': {'briefSummary': 'Data of demographic, clinical, laboratory and imaging studies of living donor liver transplantation (LDLT) recipients from two transplant centers were collected. Survival and morbidity rates between patients with and without portal vein thrombosis (PVT) were compared. Risk factors of mortality in the setting of PVT were identified. Intraoperative portal flow measurements were compared before and after portal flow restoration.', 'detailedDescription': 'LDLTs performed in two experienced centers (Ankara University Ibn-i Sina Hospital and Ankara Güven Hospital) between January 2013 and February 2020 were evaluated and included in the cohort study. Deceased donor liver transplants and pediatric transplants (deceased or living) were excluded from the study.\n\nData relating to this study including patient history, preoperative laboratory and imaging test results, reports of surgical procedures or interventions, intraoperative anesthesia records, post-operative laboratory trends, and postoperative complications were extracted from the computer-based data management system and prospectively maintained in transplant databases in both centers. Recipients of LDLT were divided in two groups according to the presence or absence of PVT.\n\nPortal flow measurements were recorded with VeriQ (Medistim ASA, Oslo, Norway) Doppler flowmeter device in one of the centers later in the study period.\n\nThe follow-up and recordings of the patients were maintained in the outpatient clinics of the two centers.\n\nThe most serious complication experienced by each patient was recorded according to the Clavien-Dindo classification Primary outcome of the current study was the survival rates of patients with and without PVT Secondary outcomes of the study included morbidity in patients with and without PVT after LDLT, risk factors of mortality after LDLT to patients with PVT and comparison of intraoperative portal flow measurements between patients with and without PVT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients that who underwent living donor liver transplantation in the study period in the two centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent liver transplantation\n\nExclusion Criteria:\n\n* Pediatric liver transplants\n* Deceased donor liver transplants'}, 'identificationModule': {'nctId': 'NCT05132192', 'briefTitle': 'Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Outcomes of Surgical Strategies for Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis', 'orgStudyIdInfo': {'id': 'PVT-LDLT-ANK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PVT', 'description': 'Patients with pretransplant portal vein thrombosis', 'interventionNames': ['Procedure: living donor liver transplantation', 'Procedure: Thrombectomy or interposition graft']}, {'label': 'non-PVT', 'description': 'Patients without pretransplant portal vein thrombosis', 'interventionNames': ['Procedure: living donor liver transplantation']}], 'interventions': [{'name': 'living donor liver transplantation', 'type': 'PROCEDURE', 'description': 'Living donor liver transplantation', 'armGroupLabels': ['PVT', 'non-PVT']}, {'name': 'Thrombectomy or interposition graft', 'type': 'PROCEDURE', 'description': 'Portal flow restoration due to PVT in any manner', 'armGroupLabels': ['PVT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elvan O Kirimker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elvan Onur Kirimker', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara University', 'class': 'OTHER'}, {'name': 'Ankara Guven Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending surgeon at Dept of Surgery', 'investigatorFullName': 'Elvan Onur Kirimker', 'investigatorAffiliation': 'Ankara University'}}}}