The Regenerative Capacity of the Donor Liver After Living Donor Liver Transplantation: an Ambidirectional Cohort Study
Enrolling by invitation
Conditions studied: Living Donor Liver Transplantation
In brief
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 Nevertheless, these studies are outdated and do not reflect current clinical practice or recent advancements.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.
Key facts
- Study ID
- NCT07329296
- Run by
- Erasmus Medical Center
- People needed
- 90
- Starts
- 2026-02-01
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-01-09
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
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:
- 18-60 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…
- There are no exclusion criteria for this study.
- Exclusion criteria for LDLT were:
- Absolute exclusion criteria
- 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
- Human immunodeficiency virus-positive persons. Relative exclusion criteria
- BMI >33 kg/m2
- Smoking
Where it is running
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands
Full record on ClinicalTrials.gov
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