The Regenerative Capacity of the Donor Liver After Living Donor Liver Transplantation: an Ambidirectional Cohort Study

NCT07329296 | Enrolling By Invitation DMC

• 1 other identifier: MEC-2025-0362
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Living donor liver transplantation (LDLT) offers a promising solution to the organ shortage. During living liver donation, a substantial portion of the donor's liver is resected. Fortunately, the liver has a remarkable capacity to regenerate. However, liver regeneration varies among individuals. Previous studies have identified several clinical factors as potential predictors of regenerative capacity. Nevertheless, these studies are outdated and do not reflect current clinical practice or recent advancements. This study aims to investigate the regenerative capacity of the donor liver following LDLT and identify its clinical predictors. It is hypothesized that the liver regenerates to the original size. Objectives: The main objective of this study is to evaluate the regenerative capacity of the donor liver following LDLT. The secondary objective is to identify clinical predictors of the regenerative capacity of the donor liver following LDLT. Study type: This is an ambidirectional, single-center cohort study using medical records. Study population: The population consists of adult living liver donors aged 18-60 years at the Erasmus MC who donate(d) between May 2004 and June 2026 and gave written informed consent. Methods: General, graft weight and liver volumetry data will be extracted from HiX. The study coordinator will register his findings and analyze them. The paired samples t-test will be used to test for differences in mean remnant liver volume and liver volume 12 months post-donation. In addition, subgroup analyses will be performed for sex, age, weight, type of liver graft donation, anatomical variants, liver steatosis, and donor complications. Multiple linear regression analysis will be performed for sex, age, BMI, donor length of stay, remnant liver volume and percentage, and type of liver graft donation.

Conditions

Living Donor Liver Transplantation

Keywords

Liver Transplantation; Living Donor; Magnetic Resonance Imaging; Liver Regeneration

Outcome Measures

Primary Outcomes (1)

• Liver regeneration

  The primary outcomes are remnant liver volume (RLV), assessed by subtracting the graft weight from the volume pre-donation, and the liver volume 12 months post-donation. Liver volumes are assessed with CT- or MRI-volumetry.

  Preoperative during screening for living liver donation and 1 year post-donation.

Secondary Outcomes (1)

• Predictors

  Preoperative during screening for living liver donation and during follow-up until 1 year post-donation.

Study Arms (1)

Living liver donors

The population consists of adult living liver donors at the Erasmus MC.

Procedure: Living liver donation

Interventions

Living liver donation PROCEDURE

Adults who underwent living liver donation.

Living liver donors

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of adult living liver donors at the Erasmus MC.

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Living liver donation between May 2004 and June 2026
• Written informed consent
• In order to be eligible for LDLT, a subject needed to meet all of the following criteria:
• years old
• Physical and mental well-being
• Body Mass Index (BMI) \<33 kg/m2
• No active drugs or other substances use

You may not qualify if:

• Medical conditions (for instance heart disease and bleeding or clotting disorders)
• History of liver disease
• Previous/active malaria infection
• Financial incentive or indications of pressure
• Unable to cooperate with designated long-term follow-up
• Severe psychiatric disease or psychological instability
• Active alcoholism or frequent heavy alcohol use or drugs use/abuse
• Unable to give informed consent
• History of dementia or other neurological degenerative disorders
• Persons with rabies or persons bitten in the past 6 months by an animal and that are treated as if the animal is rabid
• Persons with syphilis
• BMI \>33 kg/m2
• Smoking

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (3)

• Pomfret EA, Pomposelli JJ, Gordon FD, Erbay N, Lyn Price L, Lewis WD, Jenkins RL. Liver regeneration and surgical outcome in donors of right-lobe liver grafts. Transplantation. 2003 Jul 15;76(1):5-10. doi: 10.1097/01.TP.0000079064.08263.8E.

  PMID: 12865779 BACKGROUND

• Michalopoulos GK. Liver regeneration. J Cell Physiol. 2007 Nov;213(2):286-300. doi: 10.1002/jcp.21172.

  PMID: 17559071 BACKGROUND

• Yim SH, Kim DG, Kang M, Koh HH, Choi MC, Min EK, Lee JG, Kim MS, Joo DJ. Survival benefit of living-donor liver transplantation in patients with a model for end-stage liver disease over 30 in a region with severe organ shortage: a retrospective cohort study. Int J Surg. 2023 Nov 1;109(11):3459-3466. doi: 10.1097/JS9.0000000000000634.

  PMID: 37565633 BACKGROUND

Study Officials

• Robert C. Minnee, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: (Underlying) data will be made available alongside with the publication. It will be available for 10 years. Access to the data and images is approved by the head of department and principal investigator. This access is temporarily. To whom and when access approved is registered.
• Access Criteria: The PI will verify the authenticity of the requesting researcher and will check whether their intentions are in line with the informed consent and whether the intended methodology is suitable and will approve the request before providing access to the data. Other researchers could express their interest in the dataset through countersigned DTA. After meeting the sharing and reuse conditions as described above and approval of the PI, data access will be provided through the data repository.

Locations

NL (1)