Longitudinal Follow-up and Health-Related Outcomes in Liver Transplant Recipients and Living Donors

NCT07301853 — Recruiting, 9999 participants, Second Affiliated Hospital, Zhejiang University, School of Medicine

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Registry	NCT07301853
Status	Recruiting
Study type	Observational
Enrollment	9999 (Estimated)
Sponsor	Second Affiliated Hospital, Zhejiang University, School of Medicine (Other); collaborators: Mukogawa Women's University
Conditions	Living Donor Liver Transplantation Recipients, Deceased Donor Liver Transplantation Recipients, Living Liver Donor
Interventions	liver transplantation, Living Donor Hepatectomy (Procedure)
Dates	start 2025-11-24, primary completion 2045-12-31 (estimated), completion 2045-12-31 (estimated), first posted 2025-12-24, last updated 2025-12-24
Locations	1 site in China

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
recipients		Procedure: liver transplantation	A 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 Hepatectomy	A healthy person who donated a portion of their healthy liver to someone with liver failure.

liver transplantation (Procedure): 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 Hepatectomy (Procedure): Living donors undergo standard hepatectomy procedures. Postoperative recovery and long-term health outcomes are monitored through routine follow-up visits and assessments.

+Outcome measures

Primary outcomes

Long-term Incidence of Postoperative Adverse Events [From date of surgery up to 20 years]: Evaluation of the cumulative incidence of postoperative complications

Secondary outcomes

Overall Survival [Up to 20 years]
Graft Survival Rate [Up to 20 years]
Patient-Reported Outcome questionnaire [Baseline and annually up to 20 years]: 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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. 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);
2. Age 18 years or older;
3. Willing to participate in the long-term follow-up management program;
4. Signed informed consent form;

Exclusion Criteria:

1. Patients undergoing combined organ transplantation
2. Patients with severe mental illness or cognitive impairment who are unable to cooperate with follow-up assessments.
3. Donors whose surgery is aborted intraoperatively for any reason.
4. Unable or unwilling to comply with the long-term follow-up schedule.

+Locations (1)

Facility	City	Country	Status
The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou, Zhejiang	China	Recruiting

+Investigators

Wen Fang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine