Rapid Assessment of Donor Liver Quality

NCT03647059 | Unknown

• 1 other identifier: SHLTQC-2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Aims：

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

Conditions

Transplant; Failure, Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• HE section staining pathological examination

  1 week

Other Outcomes (1)

• Clinical examinations

  1 week

Study Arms (1)

LSCM examination

Diagnostic Test: LSCM examination

Interventions

LSCM examination DIAGNOSTIC_TEST

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

LSCM examination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All donor livers to be used for liver transplantations

You may not qualify if:

• Removal of blood type incompatible patients for transplantation
• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

we just need to cut a little piece of donor liver to conduct a examination of Laser scanning Confocal Microscopy(LSCM)

Study Officials

• Zhong Lin, doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong Lin, Doctor

CONTACT

13917603139; fox2189@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of hepatobiliary surgery

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 27, 2018
• Study Start: August 15, 2018
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2022
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)