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Rapid Assessment of Donor Liver Quality

Real-time Noninvasive Assessment of Donor Liver Quality

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03647059
Enrollment
300
Registered
2018-08-27
Start date
2018-08-15
Completion date
2022-08-15
Last updated
2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant; Failure, Liver

Brief summary

Aims: 1. Conduct multi-center, prospective and open research on liver quality assessment and establish LSCM liver quality assessment system 2. Classification of liver quality grades by LSCM for different pathological conditions (steatosis, fibrosis, hepatocyte necrosis, etc.) 3. Compare the specificity and sensitivity of LSCM evaluation results with the results of liver donor quality evaluation and intraoperative pathological biopsy results. 4. LSCM classifies the quality of donor liver and compares the recovery of liver function on the first day after liver transplantation. 5. LSCM grades the quality of donor liver and compares the long-term prognosis

Interventions

DIAGNOSTIC_TESTLSCM examination

Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* All donor livers to be used for liver transplantations

Exclusion criteria

* Exclusion of multiple organ transplantation * Exclusion of detached transplantation and partial liver transplantation, etc. * Removal of blood type incompatible patients for transplantation * Exclusion of poor donor liver quality due to surgical technique (such as hepatic artery embolization) , portal vein thrombosis, etc.) * 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. * Can not complete routine research follow-up, and other circumstances that the investigator believes are not suitable for the experiment.

Design outcomes

Primary

MeasureTime frameDescription
LSCM examination results1 dayLSCM examination is focus on the detections of the hepatocyte nucleus and the micro structures(such as the micro-circulation、central vein and so on).

Secondary

MeasureTime frameDescription
HE section staining pathological examination1 weekAll 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).

Other

MeasureTime frameDescription
Clinical examinations1 weekMainly focus on the examinations such as ALT、AST、LDH and so on.

Countries

China

Contacts

Primary ContactZhong Lin, Doctor
fox2189@163.com13917603139

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026