Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-09 @ 5:34 AM
Study NCT ID:
NCT03673033
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biliary Complications in Live Donor Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development of biliary complication in the first month after liver transplantation', 'timeFrame': '1 month', 'description': 'biliary complication at the first month after transplantation and whether this complication is interfered with or not will be evaluated.'}], 'secondaryOutcomes': [{'measure': 'development of biliary complication in the three months after liver transplantation', 'timeFrame': '3 months', 'description': 'biliary complication at the third month after transplantation and whether this complication is interfered with or not will be evaluated.'}, {'measure': 'development of biliary complication in the six month after liver transplantation', 'timeFrame': '6 months', 'description': 'biliary complication at the sixth month after transplantation and whether this complication is interfered with or not will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transplantation, Hepatic, Cirrhosis, Bile duct'], 'conditions': ['Biliary Stricture', 'Bile Duct Stenosi', 'Bile Leak', 'Bile Duct Injury']}, 'descriptionModule': {'briefSummary': 'The study was designed as a prospective cohort study. The effects of hot and cold ischemic times during live donor liver transplantation on postoperative 1-3 and 6 month follow up biliary complications will be investigated.', 'detailedDescription': 'The invastigators will record the age, gender, weight, diagnosis, presence of hcc (hepatocellular carcinoma), whether transcatheter embolization (transarterial radiolabelization) is performed, meld score, age of donor, gender, graft hepatic artery diameter, bile duct diameter and number before surgery.\n\nDuring the operation,\n\nThe duration of ischemia will be evaluated as three stages.\n\nDuring the first stage donor hepatectomy, the time from the interruption of the hepatic artery to the first administration of the solution to the bile ducts on the back table will be recorded and recorded as the first ischemia time.\n\nThe time from the administration of the solution to the biliary system on the stage 2 back-to-back table until the cold anastomosis is performed will be recorded as the duration of cold ischemia.\n\nThe time from the third graft to receipt of the graft to the end of the hepatic artery anastomosis will be recorded as the second ischemia time.\n\nThe duration of operation, whether or not pringle maneuvers were performed, hepatic artery thrombus, graft bile number, number of bile anastomoses, lowest biliary tract diameter and hepatic artery diameter\n\nAfter the surgery,\n\nThe use of immunosuppression (Tacrolimus, certican or combined use) will be recorded.\n\nDuring the follow-up period of 1,3,6 months, complaints of the patients, laboratory values and imaging methods as well as whether or not there is biliary complication (leakage, stenosis) will be recorded.\n\nIf the complication develops during follow-up, the procedure (follow-up, ercp, ptk, surgery) will be recorded.\n\nSince the study is observational, normal treatment will not be involved.\n\nParticipants will not be included in the study in the presence of hepaticojejunostomy patients, cadaveric transplant patients, pediatric transplant patients, Cmv infection, hepatic artery thrombosis, portal thrombosis, acute rejection in the first operation.\n\nParticipants with live donor liver transplant patients, multiple gallbladder anastomoses or single bile duct multiple anastomoses will be included.\n\nWhen the power analysis for the study was taken as α = 0.05 and 1-β (power) = 0,80, it was calculated that at least 99 patients should be taken to have a difference of 38% in the rates of biliary complication in cold ischemia.\n\nThe demographic and all findings of the disease will be collected at excell and at the end of the study all the findings will be statistically evaluated and the results will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with live donor liver transplant for any reason', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nLive donor liver transplantation Emergency Live donor liver transplantation Multiple or single bile duct anastomosis in liver transplantation\n\nExclusion Criteria:\n\nHepaticojejunostomy Cadaveric liver transplantation Pediatric liver transplantation Cmv infection presence Hepatic arterial thrombus Porta thrombus Acute rejection'}, 'identificationModule': {'nctId': 'NCT03673033', 'briefTitle': 'Biliary Complications in Live Donor Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Can the Effects of Cold and Hot Ischemia Time on Biliary Complications in Live Donor Liver Transplantation Be Classified?', 'orgStudyIdInfo': {'id': '2018/18'}}, 'armsInterventionsModule': {'interventions': [{'name': 'liver transplantation', 'type': 'PROCEDURE', 'description': 'calculation of hot and cold ischemia durations from donor artery cut-off time in liver transplantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44090', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Cihan Gokler', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'data will be available within 6 months of study completion', 'ipdSharing': 'YES', 'description': 'de-identified individual participant data for all primary, secondary and tertiary outcome measures will be made available', 'accessCriteria': 'data access request will be reviewed by an external independent review panel.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal invastigator', 'investigatorFullName': 'cihan gokler', 'investigatorAffiliation': 'Inonu University'}}}}