Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 4:56 PM
Study NCT ID:
NCT03647059
Status:
UNKNOWN
Last Update Posted:
2018-08-27
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Assessment of Donor Liver Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'we just need to cut a little piece of donor liver to conduct a examination of Laser scanning Confocal Microscopy(LSCM)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical examinations', 'timeFrame': '1 week', 'description': 'Mainly focus on the examinations such as ALT、AST、LDH and so on.'}], 'primaryOutcomes': [{'measure': 'LSCM examination results', 'timeFrame': '1 day', 'description': 'LSCM examination is focus on the detections of the hepatocyte nucleus and the micro structures(such as the micro-circulation、central vein and so on).'}], 'secondaryOutcomes': [{'measure': 'HE section staining pathological examination', 'timeFrame': '1 week', 'description': 'All of donor livers must be detected by HE section staining pathological examination and it is mainly focused on the detection of hepatocyte nucleus and the micro structures(such as the micro-circulation、central vein and so on).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transplant; Failure, Liver']}, 'descriptionModule': {'briefSummary': 'Aims：\n\n1. Conduct multi-center, prospective and open research on liver quality assessment and establish LSCM liver quality assessment system\n2. Classification of liver quality grades by LSCM for different pathological conditions (steatosis, fibrosis, hepatocyte necrosis, etc.)\n3. Compare the specificity and sensitivity of LSCM evaluation results with the results of liver donor quality evaluation and intraoperative pathological biopsy results.\n4. LSCM classifies the quality of donor liver and compares the recovery of liver function on the first day after liver transplantation.\n5. LSCM grades the quality of donor liver and compares the long-term prognosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All donor livers to be used for liver transplantations. Before transplant, the donor liver will be stored in the cold-UW solution in ice water. We just cut a piece of liver simple in the any place of donor liver, usually, we always cut a piece of liver simple from the edge of the donor liver.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All donor livers to be used for liver transplantations\n\nExclusion Criteria:\n\n* Exclusion of multiple organ transplantation\n* Exclusion of detached transplantation and partial liver transplantation, etc.\n* Removal of blood type incompatible patients for transplantation\n* Exclusion of poor donor liver quality due to surgical technique (such as hepatic artery embolization) , portal vein thrombosis, etc.)\n* Any form of substance abuse, mental illness or any disease that the investigator believes may interfere with the patient's understanding of the research requirements.\n* Can not complete routine research follow-up, and other circumstances that the investigator believes are not suitable for the experiment."}, 'identificationModule': {'nctId': 'NCT03647059', 'briefTitle': 'Rapid Assessment of Donor Liver Quality', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Real-time Noninvasive Assessment of Donor Liver Quality', 'orgStudyIdInfo': {'id': 'SHLTQC-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LSCM examination', 'interventionNames': ['Diagnostic Test: LSCM examination']}], 'interventions': [{'name': 'LSCM examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein', 'armGroupLabels': ['LSCM examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Zhong Lin, doctor', 'role': 'CONTACT', 'email': 'fox2189@163.com', 'phone': '18817592189'}], 'facility': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhong Lin, Doctor', 'role': 'CONTACT', 'email': 'fox2189@163.com', 'phone': '13917603139'}], 'overallOfficials': [{'name': 'Zhong Lin, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'positive IPD is available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of hepatobiliary surgery', 'investigatorFullName': 'Lin Zhong', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}