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

NCT07301853 | Recruiting

• 1 other identifier: 2025-0793
• Study Type: observational
• Target: 9,999
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Living Donor Liver Transplantation Recipients; Deceased Donor Liver Transplantation Recipients; Living Liver Donor

Keywords

liver transplantation; living donors; transplant recipients; follow-up studies

Outcome Measures

Primary Outcomes (1)

• Long-term Incidence of Postoperative Adverse Events

  Evaluation of the cumulative incidence of postoperative complications

  From date of surgery up to 20 years

Secondary Outcomes (3)

• Overall Survival

  Up to 20 years

• Graft Survival Rate

  Up to 20 years

• Patient-Reported Outcome questionnaire

  Baseline and annually up to 20 years

Study Arms (2)

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

living donors

A healthy person who donated a portion of their healthy liver to someone with liver failure.

Procedure: Living Donor Hepatectomy

Interventions

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.

recipients

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.

living donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mukogawa Women's University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Wen Fang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Fang

CONTACT

19705094680; wenfang@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 31, 2045
• Study Completion (Estimated): December 31, 2045
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

CN (1)