Transplant; Failure, LiverNCT03647059
Rapid Assessment of Donor Liver Quality
An observational study of Transplant; Failure, Liver, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transplant; Failure, Liver
- What is being tested?
- LSCM examination
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2018to 15 Aug 2022
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All donor livers to be used for liver transplantations
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200080
Zhong Lin, doctor, 18817592189, fox2189@163.com
About this study
Official title: Real-time Noninvasive Assessment of Donor Liver Quality
Aims：
- 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
- Conditions
- Transplant; Failure, Liver
- Being tested
- LSCM examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSCM examinationDiagnostic test
Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein
| Study group | Role | What they receive |
|---|---|---|
| LSCM examination | Not described Receives: Diagnostic Test: LSCM examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (1)
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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start15 Aug 2018 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Failure, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Zhong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhong Lin, doctor, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647059
- Sponsor's protocol ID
- SHLTQC-2
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: positive IPD is available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Noninvasive Assessment of Donor Liver Quality
- ClinicalTrials.gov ID
- NCT03647059
- Acronym / sponsor ID
- SHLTQC-2
- Conditions
- Transplant; Failure, Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Aug 2018 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims：
- 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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LSCM examination | – | Diagnostic Test: LSCM examination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All donor livers to be used for liver transplantations
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSCM examinationCut a piece of donor liver and conduct the LSCM examination after staining fluorescein | Diagnostic test | LSCM examination |
Primary outcome
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).
1 secondary outcome
HE section staining pathological examination
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Individual participant dataSharing planned: Yes. positive IPD is available to other researchers
Related trials for Transplant; Failure, Liver
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
RecruitingObservational study
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Heart Failure, Liver Fibrosis
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhong Lin, doctor principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant; Failure, Liver, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Lin, Doctor (13917603139, fox2189@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LSCM examination results (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.