Rapid Assessment of Donor Liver Quality

• Conditions: Transplant; Failure, Liver

• Registration Number: NCT03647059
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-09
• Study Start: 2018-08-15
• Study First Submitted QC: 2018-08-22
• Last Update Submitted: 2018-08-22
• Study First Posted: 2018-08-27
• Last Update Posted: 2018-08-27
• Primary Completion: 2020-08-15
• Study Completion: 2022-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LSCM examination results	1 day	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).

Secondary Outcome Measures

Name	Time	Method
HE section staining pathological examination	1 week	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).

Trial Locations

Locations (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China