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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
Sponsor:
Information provided by (Responsible Party):
Lin Zhong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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

Condition or disease Intervention/treatment
Transplant; Failure, Liver Diagnostic Test: LSCM examination

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. Clinical examinations [ Time Frame: 1 week ]
    Mainly focus on the examinations such as ALT、AST、LDH and so on.


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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647059


Contacts
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Contact: Zhong Lin, Doctor 13917603139 fox2189@163.com

Locations
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China, Shanghai
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200080
Contact: Zhong Lin, doctor    18817592189    fox2189@163.com   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Zhong Lin, doctor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Additional Information:

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Responsible Party: Lin Zhong, Director of hepatobiliary surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03647059     History of Changes
Other Study ID Numbers: SHLTQC-2
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: positive IPD is available to other researchers
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No