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.

Study Overview

• Status: Recruiting
• Conditions: Living Donor Liver Transplantation Recipients; Deceased Donor Liver Transplantation Recipients; Living Liver Donor
• Intervention / Treatment: Procedure: liver transplantation; Procedure: Living Donor Hepatectomy

• Study Type: Observational
• Enrollment (Estimated): 9999

Contacts and Locations

• Study Contact: Name: Wen Fang; Phone Number: 19705094680; Email: wenfang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • the Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Wen Fang; Phone Number: 19705094680; Email: wenfang@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
recipients; A patient who received a new, healthy liver (or part of one from a living donor) to replace their own diseased liver	Procedure: liver transplantation; 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 donors; A healthy person who donated a portion of their healthy liver to someone with liver failure.	Procedure: Living Donor Hepatectomy; Living donors undergo standard hepatectomy procedures. Postoperative recovery and long-term health outcomes are monitored through routine follow-up visits and assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Incidence of Postoperative Adverse Events	Evaluation of the cumulative incidence of postoperative complications	From date of surgery up to 20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		Up to 20 years
Graft Survival Rate		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	Baseline and annually up to 20 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Mukogawa Women's University
• Investigators: Principal Investigator: Wen Fang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): December 31, 2045
• Study Completion (Estimated): December 31, 2045

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: liver transplantation; transplant recipients; follow-up studies; living donors
• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Transplantation; Digestive System Surgical Procedures; Cell- and Tissue-Based Therapy; Biological Therapy; Tissue Transplantation; Organ Transplantation; Liver Transplantation
• Other Study ID Numbers: 2025-0793

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No