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Living Donor Liver TransplantationSILDLTNCT07015723

Steatosis Assessment Pre-LDLT

An observational study of Living Donor Liver Transplantation, run by Erasmus Medical Center at 1 site in Netherlands.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

There is a major shortage of donor livers in the Netherlands. Living donor liver transplantation (LDLT) is a good solution to this shortage. Donor screening is extensive to minimalize risks for donors and recipients. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Living Donor Liver Transplantation
What is being tested?
Living liver donors
Type of treatment
Surgery or procedure
How many people
90 participants
Where
1 siteNetherlands
Study dates
1 Jan 2026to 31 Dec 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • Living liver donation between May 2004 and June 2026 at the Erasmus MC
  • Written informed consent

Who cannot join

  • There are no exclusion criteria for this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

Official title: The Correlation Between MRCP and Biopsy Pre-LDLT for Liver Steatosis Assessment: an Ambidirectional Cohort Study

There is a major shortage of donor livers in the Netherlands. Living donor liver transplantation (LDLT) is a good solution to this shortage. Donor screening is extensive to minimalize risks for donors and recipients. During screening, the vascular anatomy of the liver is assessed with CT, the bile duct anatomy with MRCP, and liver steatosis with a biopsy. Biopsy is an invasive intervention with some risk of complications. MRCP can aid in steatosis assessment. Previous research suggested that biopsy can be performed on indication. However, the sensitivity of detecting different steatosis percentages on MRCP varies widely, which makes determining the degree of steatosis difficult and less reliable. This project investigates whether MRCP is equally adequate as biopsy in assessing liver steatosis. It may lead to a faster, less burdensome and minimal invasive screening process.

Read the detailed description

Research methods:

General and biopsy data (liver steatosis percentage) and MRCP images will be extracted from HiX. Screenshots of the images will be made. All personal data will be blacked out using Microsoft Powerpoint 16.90.2. The MRCP-images and biopsy data will be coded at random with different codes for the MRCP and biopsy of the same donor. The coded images will be shared with the radiologist through Castor. He will assess liver steatosis on MRCP. He will register his findings in Castor and share this file with the study coordinator.

Analysis:

Normality will be tested using the Shapiro-Wilk test. Homogeneity of variances will be tested using the F-test. A QQ-plot will be used to check for outliers. For the baseline donor characteristics, sex differences will be investigated for age, weight, height, and BMI using the unpaired samples t-test or Mann-Whitney test.

Similarities and differences between liver steatosis assessment on MRCP and biopsy will be thoroughly described.

The mean (Standard Deviation (SD)) percentage of liver steatosis will be calculated for MRCP and for biopsy. The correlations between MRCP and biopsy will be calculated by the following formula: (mean percentage on MRCP)/(mean percentage on biopsy)*100(%). For the mean correlation, the average of all donors' correlations will be taken. A table showing the means (SD) and min-max of the percentage of liver steatosis, and the correlation will be made. The distribution of correlations will be shown in a bar chart. The paired samples t-test will be used to test for differences in the mean percentage of liver steatosis on MRCP and biopsy. Subgroup analyses will be carried out for sex, age, weight, height, and BMI using the unpaired samples t-test, Welch's t-test, or Mann-Whitney test Statistical analyses will be carried out using RStudio 2024.09.1, GraphPad Prism 9.5.0, and Microsoft Excel version 16.90.2. P<0.05 indicates statistical significance.

Recruitment and informed consent procedures The transplant coordinator and/or transplant surgeon will inform participants about the study and will ask their written informed consent. Living liver donors are followed up annually for life. The participants will be informed during a follow-up consult. All donors who are, for whatever reason, not visiting the Erasmus MC anymore for follow-up are contacted by phone. If the donor considers participating, a Patient Information Form (PIF) will be sent by mail. The donors can return the signed PIF through mail.

Donors can withdraw their informed consent at any time and for any reason if they wish to do so without any consequences. They can withdraw through phone, mail, or in person.

Privacy protection Subject's privacy is protected by using coded data. In the database subjects are referred to as numbers. These numbers are chosen at random. Which number belongs to which subject is registered in a key table with a password. This password is only known by the principal investigator and the research team. The database in which the data is stored (Castor), meets the requirements set for data security. The handling of personal data is in compliance with the Dutch Data Protection Act (in Dutch: 'Algemene Verordening Gegevensbescherming (AVG)). Only the code number will be used for study documentation, progress reports, and research publications.

Being tested
Living liver donors
Keywords
Liver Transplantation, Living Donor, Magnetic Resonance Imaging, Biopsy, Anatomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Living liver donorsProcedure or surgery

    Adults who are screened for living liver donation.

Study groups in NCT07015723
Study groupRoleWhat they receive
Living liver donorsThe population consists of adult living liver donors at the Erasmus MC.
Receives: Procedure: Living liver donors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liver steatosis

    The primary outcome is the percentage of liver steatosis.

    Measured: Preoperative during screening for living liver donation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
90 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015723
Sponsor's protocol ID
14060
Acronym
SILDLT
Status last verified
Jun 2025
First submitted
4 Jun 2025
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol, documentation, data management plan, data analysis plan, script to assess data, scripts to analyse data, scripts to generate tables and figures in the publication.

Publications

  • Testa G, Nadalin S, Klair T, Florman S, Balci D, Frola C, Spiro M, Raptis DA, Selzner M; ERAS4OLT.org working group. Optimal surgical workup to ensure safe recovery of the donor after living liver donation - A systematic review of the literature and expert panel recommendations. Clin Transplant. 2022 Oct;36(10):e14641. doi: 10.1111/ctr.14641.

    PubMed 35258132

  • 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.

    PubMed 37565633

  • Jackson WE, Malamon JS, Kaplan B, Saben JL, Schold JD, Pomposelli JJ, Pomfret EA. Survival Benefit of Living-Donor Liver Transplant. JAMA Surg. 2022 Oct 1;157(10):926-932. doi: 10.1001/jamasurg.2022.3327.

    PubMed 35921119

  • Ter Burg HW, Chorley Rn AJ, Polak WG, Kranenburg LW, Boehnert MU, Minnee RC. Older living liver donors can enlarge the donor pool: a systematic review and meta-analysis. Int J Surg. 2024 Aug 1;110(8):5022-5033. doi: 10.1097/JS9.0000000000001419.

    PubMed 38573086

Questions about this trial

What is this clinical trial studying?

An observational study of Living Donor Liver Transplantation, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver steatosis (time frame: Preoperative during screening for living liver donation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07015723, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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