Rapid Assessment of Donor Liver Quality

Real-time Noninvasive Assessment of Donor Liver Quality

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

Study Overview

• Status: Unknown
• Conditions: Transplant; Failure, Liver
• Intervention / Treatment: Diagnostic test: LSCM examination

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LSCM examination	Diagnostic test: LSCM examination; Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LSCM examination results	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).	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HE section staining pathological examination	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).	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical examinations	Mainly focus on the examinations such as ALT、AST、LDH and so on.	1 week

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Zhong Lin, doctor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2018
• Primary Completion (Anticipated): August 15, 2020
• Study Completion (Anticipated): August 15, 2022

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SHLTQC-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: positive IPD is available to other researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No