Liver TransplantationNCT06188273
Impact of Skeletal Muscle Quality and Loss on the Outcome of Liver Transplantation
An observational study of Liver Transplantation and Muscle Loss, run by Zhejiang University.
Trial summary
CT imaging-based skeletal muscle assessment has been found to predict the outcomes of many diseases. Previous evidence revealed that pre-transplant muscle quality and post-transplant muscle loss were associated with transplant outcomes. However, there is no prospective study supporting the aforementioned conclusions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplantation, Muscle Loss, Muscle Quality
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Liver transplant patients from multiple transplant centers in China
Who may be able to join
- Adult patients undergoing deceased donor liver transplantation (DDLT) for the first time
Who cannot join
- Pediatric transplants
- Presence of portal vein tumor thrombus according to imageing before transplantation
- Presence of macrovascular invasion according to imageing before transplantation
- Re-transplants
- Multi-organ transplants
- Patients who died within 30 days after transplantation
- Patients diagnosed with skeletal muscle diseases (e.g. muscle atrophy)
- Patients with serious medical conditions such as heart failure, persistent infection, and renal insufficiency.
About this study
CT imaging-based skeletal muscle assessment has been found to predict the outcomes of many diseases. Previous evidence revealed that pre-transplant muscle quality and post-transplant muscle loss were associated with transplant outcomes. However, there is no prospective study supporting the aforementioned conclusions. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant CT images as well as post-transplant CT images at specific time points. The objective is to further explore and clarify the correlation between skeletal muscle assessment and the prognosis of liver transplant patients. The goal is to provide guidance for peri-transplant health monitoring and disease intervention for liver transplant patients.
- Conditions
- Liver Transplantation, Muscle Loss, Muscle Quality
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myosteatotic Group | The group of patients was diagnosed with myosteatosis through CT imaging assessment before transplantation. | |
| Non-myosteatotic Group | The group of patients was diagnosed without myosteatosis through CT imaging assessment before transplantation. | |
| The Group with Severe Muscle Loss | The group of patients, through the comparison of CT images before and after transplantation, was diagnosed with significant muscle loss. | |
| The Group without Severe Muscle Loss | The group of patients, through the comparison of CT images before and after transplantation, was diagnosed without significant muscle loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mortality
Measured: 2024.1.1-2027.1.1
Postoperative recurrence of liver cancer
Specifically for the included patients who undergo liver transplantation for liver cancer
Measured: 2024.1.1-2027.1.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Shulan (Hangzhou) Hospital, The Affiliated Hospital of Qingdao University, West China Hospital, Huashan Hospital
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188273
- Sponsor's protocol ID
- CT2023-ZJU-OBS3
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Skeletal Muscle Quality and Loss on the Outcome of Liver Transplantation
- ClinicalTrials.gov ID
- NCT06188273
- Acronym / sponsor ID
- CT2023-ZJU-OBS3
- Conditions
- Liver Transplantation, Muscle Loss, Muscle Quality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Shulan (Hangzhou) Hospital, The Affiliated Hospital of Qingdao University, West China Hospital, Huashan Hospital
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 3 Jan 2024 (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.
CT imaging-based skeletal muscle assessment has been found to predict the outcomes of many diseases. Previous evidence revealed that pre-transplant muscle quality and post-transplant muscle loss were associated with transplant outcomes. However, there is no prospective study supporting the aforementioned conclusions. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant CT images as well as post-transplant CT images at specific time points. The objective is to further explore and clarify the correlation between skeletal muscle assessment and the prognosis of liver transplant patients. The goal is to provide guidance for peri-transplant health monitoring and disease intervention for liver transplant patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Myosteatotic Group | – | –The group of patients was diagnosed with myosteatosis through CT imaging assessment before transplantation. |
| Non-myosteatotic Group | – | –The group of patients was diagnosed without myosteatosis through CT imaging assessment before transplantation. |
| The Group with Severe Muscle Loss | – | –The group of patients, through the comparison of CT images before and after transplantation, was diagnosed with significant muscle loss. |
| The Group without Severe Muscle Loss | – | –The group of patients, through the comparison of CT images before and after transplantation, was diagnosed without significant muscle loss. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Liver transplant patients from multiple transplant centers in China
Key inclusion criteria (1 listed)
- Adult patients undergoing deceased donor liver transplantation (DDLT) for the first time
Key exclusion criteria (8 listed)
- Pediatric transplants
- Presence of portal vein tumor thrombus according to imageing before transplantation
- Presence of macrovascular invasion according to imageing before transplantation
- Re-transplants
- Multi-organ transplants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative mortality
Time frame: 2024.1.1-2027.1.1
Postoperative recurrence of liver cancer
Time frame: 2024.1.1-2027.1.1
Specifically for the included patients who undergo liver transplantation for liver cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Muscle Loss, run by Zhejiang University.
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 8 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: opening soon, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative mortality (time frame: 2024.1.1-2027.1.1). The study lists 2 primary outcomes in all. 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 3 Jan 2024.