Rapid Assessment of Donor Liver Quality

NCT ID: NCT03647059

Last Updated: 2018-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-15

Study Completion Date

2022-08-15

Brief Summary

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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

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Conditions

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Transplant; Failure, Liver

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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LSCM examination

LSCM examination

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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LSCM examination

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lin Zhong

Director of hepatobiliary surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhong Lin, doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Zhong Lin, Doctor

Role: CONTACT

13917603139

Facility Contacts

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Zhong Lin, doctor

Role: primary

18817592189

Other Identifiers

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SHLTQC-2

Identifier Type: -

Identifier Source: org_study_id

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