Living Donor Liver Transplantation RecipientsNCT07301853
Longitudinal Follow-up and Health-Related Outcomes in Liver Transplant Recipients and Living Donors
An observational study of Living Donor Liver Transplantation Recipients and Deceased Donor Liver Transplantation Recipients, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This prospective cohort study aims to identify risk factors for postoperative adverse events in liver transplant recipients and living donors. By collecting comprehensive clinical data and conducting systematic long-term follow-up, the researchers intend to establish a specialized, standardized, and individualized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Living Donor Liver Transplantation Recipients, Deceased Donor Liver Transplantation Recipients, Living Liver Donor
- What is being tested?
- liver transplantation and Living Donor Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 9,999 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2025to 31 Dec 2045
- How long will I take part?
- 50 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises all consecutive patients with end-stage liver disease or acute liver failure scheduled for liver transplantation (recipients) and healthy individuals undergoing living donor hepatectomy (donors) at the Department of Liver Surgery of the study center. Participants are selected from the clinical practice setting of the study center.
Who may be able to join
- Patients undergoing liver transplantation or living donor hepatectomy at the study center (living donor should be approved by the hospital ethics committee for living organ donation);
- Age 18 years or older;
- Willing to participate in the long-term follow-up management program;
- Signed informed consent form;
Who cannot join
- Patients undergoing combined organ transplantation
- Patients with severe mental illness or cognitive impairment who are unable to cooperate with follow-up assessments.
- Donors whose surgery is aborted intraoperatively for any reason.
- Unable or unwilling to comply with the long-term follow-up schedule.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Wen Fang, 19705094680, wenfang@zju.edu.cn
About this study
This prospective cohort study aims to identify risk factors for postoperative adverse events in liver transplant recipients and living donors. By collecting comprehensive clinical data and conducting systematic long-term follow-up, the researchers intend to establish a specialized, standardized, and individualized follow-up management system. The ultimate goal is to optimize intervention strategies and improve patient prognosis and quality of life for both recipients and donors.
- Conditions
- Living Donor Liver Transplantation Recipients, Deceased Donor Liver Transplantation Recipients, Living Liver Donor
- Being tested
- liver transplantation, Living Donor Hepatectomy
- Keywords
- liver transplantation, living donors, transplant recipients, follow-up studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantationProcedure or surgery
Patients undergo standard liver transplantation according to clinical protocols. Postoperative management and follow-up are conducted per routine standard of care. Clinical data, including survival, adverse events, and quality of life (assessed by questionnaires/scales), are collected observationally at regular follow-up intervals.
Living Donor HepatectomyProcedure or surgery
Living donors undergo standard hepatectomy procedures. Postoperative recovery and long-term health outcomes are monitored through routine follow-up visits and assessments.
| Study group | Role | What they receive |
|---|---|---|
| recipients | A patient who received a new, healthy liver (or part of one from a living donor) to replace their own diseased liver Receives: Procedure: liver transplantation | |
| living donors | A healthy person who donated a portion of their healthy liver to someone with liver failure. Receives: Procedure: Living Donor Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Incidence of Postoperative Adverse Events
Evaluation of the cumulative incidence of postoperative complications
Measured: From date of surgery up to 20 years
Secondary outcomes (3)
Overall Survival
Measured: Up to 20 years
Graft Survival Rate
Measured: Up to 20 years
Patient-Reported Outcome questionnaire
Assessment of multiple dimensions of patient health status, including physical functioning, mental health, social well-being, symptoms burden (e.g., pain, fatigue), and medication adherence. These domains will be evaluated using a battery of standard validated instruments
Measured: Baseline and annually up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start24 Nov 2025
- Primary completion31 Dec 2045 (estimated)
- Study completion31 Dec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor Liver Transplantation RecipientsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 9,999 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Mukogawa Women's University
- Responsible party
- Sponsor
- Investigators
- Wen Fang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301853
- Sponsor's protocol ID
- 2025-0793
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up and Health-Related Outcomes in Liver Transplant Recipients and Living Donors
- ClinicalTrials.gov ID
- NCT07301853
- Acronym / sponsor ID
- 2025-0793
- Conditions
- Living Donor Liver Transplantation Recipients, Deceased Donor Liver Transplantation Recipients, Living Liver Donor
- Keywords
- liver transplantation, living donors, transplant recipients, follow-up studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,999 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Mukogawa Women's University
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 31 Dec 2045 (estimated)
- Study completion
- 31 Dec 2045 (estimated)
- First posted
- 24 Dec 2025 (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.
This prospective cohort study aims to identify risk factors for postoperative adverse events in liver transplant recipients and living donors. By collecting comprehensive clinical data and conducting systematic long-term follow-up, the researchers intend to establish a specialized, standardized, and individualized follow-up management system. The ultimate goal is to optimize intervention strategies and improve patient prognosis and quality of life for both recipients and donors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recipients | – | Procedure: liver transplantationA patient who received a new, healthy liver (or part of one from a living donor) to replace their own diseased liver |
| living donors | – | Procedure: Living Donor HepatectomyA healthy person who donated a portion of their healthy liver to someone with liver failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises all consecutive patients with end-stage liver disease or acute liver failure scheduled for liver transplantation (recipients) and healthy individuals undergoing living donor hepatectomy (donors) at the Department of Liver Surgery of the study center. Participants are selected from the clinical practice setting of the study center.
Key inclusion criteria (4 listed)
- Patients undergoing liver transplantation or living donor hepatectomy at the study center (living donor should be approved by the hospital ethics committee for living organ donation);
- Age 18 years or older;
- Willing to participate in the long-term follow-up management program;
- Signed informed consent form;
Key exclusion criteria (4 listed)
- Patients undergoing combined organ transplantation
- Patients with severe mental illness or cognitive impairment who are unable to cooperate with follow-up assessments.
- Donors whose surgery is aborted intraoperatively for any reason.
- Unable or unwilling to comply with the long-term follow-up schedule.
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 |
|---|---|---|
| liver transplantationPatients undergo standard liver transplantation according to clinical protocols. Postoperative management and follow-up are conducted per routine standard of care. Clinical data, including survival, adverse events, and quality of life (assessed by questionnaires/scales), are collected observationally at regular follow-up intervals. | Procedure or surgery | recipients |
| Living Donor HepatectomyLiving donors undergo standard hepatectomy procedures. Postoperative recovery and long-term health outcomes are monitored through routine follow-up visits and assessments. | Procedure or surgery | living donors |
Primary outcome
Long-term Incidence of Postoperative Adverse Events
Time frame: From date of surgery up to 20 years
Evaluation of the cumulative incidence of postoperative complications
3 secondary outcomes
Overall Survival
Time frame: Up to 20 years
Graft Survival Rate
Time frame: Up to 20 years
Patient-Reported Outcome questionnaire
Time frame: Baseline and annually up to 20 years
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 24 Dec 2025.
Related trials for Living Donor Liver Transplantation Recipients
Not yet recruiting
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.
Chronic Liver Disease
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.
Wen Fang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Living Donor Liver Transplantation Recipients and Deceased Donor Liver Transplantation Recipients, run by Second Affiliated Hospital, Zhejiang 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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?
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?
Contact Wen Fang (19705094680, wenfang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term Incidence of Postoperative Adverse Events (time frame: From date of surgery up to 20 years). 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 24 Dec 2025.