Clinical trial NCT07015723: Steatosis Assessment Pre-LDLT
Official title: The Correlation Between MRCP and Biopsy Pre-LDLT for Liver Steatosis Assessment: an Ambidirectional Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Living Donor Liver Transplantation
Keywords: Liver Transplantation
Living Donor
Magnetic Resonance Imaging
Biopsy
Anatomy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists of adult living liver donors at the Erasmus MC.

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- There are no exclusion criteria for this study.

Primary outcomes:
measure: Liver steatosis
timeFrame: Preoperative during screening for living liver donation.
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South Holland
Study officials:
affiliation: Erasmus Medical Center
name: Robert C. Minnee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.