Rapid Assessment of Donor Liver Quality

Transplant; Failure, Liver Clinical Trial

Official title:

Real-time Noninvasive Assessment of Donor Liver Quality

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03647059
• Other study ID #: SHLTQC-2
• Status: Not yet recruiting
• Start date: August 15, 2018
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2018
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Zhong Lin, Doctor
• Phone: 13917603139
• Email: fox2189[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transplant; Failure, Liver

Intervention

Diagnostic Test:
• LSCM examination
Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein

Locations

Country	Name	City	State
China	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical examinations	Mainly focus on the examinations such as ALT?AST?LDH and so on.	1 week
Primary	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	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