Study Results
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Basic Information
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ENROLLING_BY_INVITATION
90 participants
OBSERVATIONAL
2026-01-01
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Living liver donors
The population consists of adult living liver donors at the Erasmus MC.
Living liver donors
Adults who are screened for living liver donation.
Interventions
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Living liver donors
Adults who are screened for living liver donation.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
18 Years
60 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Robert Minnee
Hepato-Pancreato-Biliary/Transplant Surgeon, PhD
Principal Investigators
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Robert C. Minnee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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14060
Identifier Type: -
Identifier Source: org_study_id
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