Rapid Assessment of Donor Liver Quality
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|ClinicalTrials.gov Identifier: NCT03647059|
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
- Conduct multi-center, prospective and open research on liver quality assessment and establish LSCM liver quality assessment system
- Classification of liver quality grades by LSCM for different pathological conditions (steatosis, fibrosis, hepatocyte necrosis, etc.)
- Compare the specificity and sensitivity of LSCM evaluation results with the results of liver donor quality evaluation and intraoperative pathological biopsy results.
- LSCM classifies the quality of donor liver and compares the recovery of liver function on the first day after liver transplantation.
- LSCM grades the quality of donor liver and compares the long-term prognosis
|Condition or disease||Intervention/treatment|
|Transplant; Failure, Liver||Diagnostic Test: LSCM examination|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||4 Years|
|Official Title:||Real-time Noninvasive Assessment of Donor Liver Quality|
|Estimated Study Start Date :||August 15, 2018|
|Estimated Primary Completion Date :||August 15, 2020|
|Estimated Study Completion Date :||August 15, 2022|
Diagnostic Test: LSCM examination
Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein
- LSCM examination results [ Time Frame: 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).
- HE section staining pathological examination [ Time Frame: 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).
- Clinical examinations [ Time Frame: 1 week ]Mainly focus on the examinations such as ALT、AST、LDH and so on.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647059
|Contact: Zhong Lin, Doctoremail@example.com|
|Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine|
|Shanghai, Shanghai, China, 200080|
|Contact: Zhong Lin, doctor 18817592189 firstname.lastname@example.org|
|Principal Investigator:||Zhong Lin, doctor||Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China|