The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Location status: Recruiting
Recruiting
NCT Number: NCT07301853
Longitudinal Follow-up and Health-Related Outcomes in Liver Transplant Recipients and Living Donors
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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;
Exclusion criteria
- 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.
Treatment and study plan
Liver Transplantation
ProcedurePatients 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
ProcedureLiving donors undergo standard hepatectomy procedures. Postoperative recovery and long-term health outcomes are monitored through routine follow-up visits and assessments.
Primary outcomes
-
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
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
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Collaborators
- Mukogawa Women's University
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2045
- Study completion
- 2045
- First posted
- Dec 24, 2025
- Registry last updated
- Dec 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.