Living Donor Liver TransplantationBVLDLTNCT06875232
The Correlation Between CT and MRCP Before Living Liver Donation for Liver Blood Vessel Assessment: an Ambidirectional Cohort Study
An observational study of Living Donor Liver Transplantation, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Living donor liver transplantation (LDLT) is a good solution to the donor liver shortage in the Netherlands. In cases of severe liver disease, LDLT has substantial survival benefits, fewer (future) complications, and an improved quality of life. 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
- 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
Who cannot join
- There are no exclusion criteria for this study.
- 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
Show all 16Show fewer
- 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
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
About this study
Official title: The Correlation Between CT and MRCP Pre-LDLT for Liver Blood Vessel Assessment: an Ambidirectional Cohort Study
Living donor liver transplantation (LDLT) is a good solution to the donor liver shortage in the Netherlands. In cases of severe liver disease, LDLT has substantial survival benefits, fewer (future) complications, and an improved quality of life.
Donor screening is extensive to minimize risks for both donors and recipients. The liver's blood vessels are assessed using CT and the bile ducts with MRCP. Blood vessel assessment can also be performed using MRCP, which would make the CT unnecessary. Before CT can be removed from the screening procedure, the correlation between blood vessel assessment on CT and MRCP must be clarified.
It is hypothesized that CT is equally adequate in assessing liver blood vessels to MRCP.
Read the detailed description
Research methods:
Data, CT-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 CT- and MRCP-images will be coded at random with different codes for the CT and MRCP of the same donor. These coded images will be shared with the radiologist through Castor. He will count the blood vessels and look for focal liver lesions. 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 blood vessel assessment on CT and MRCP will be thoroughly described.
The mean (Standard Deviation (SD)) number of total essential blood vessels will be calculated for CT and for MRCP. The correlations between CT and MRCP will be calculated by the following formula: (mean number on CT)/(mean number on MRCP)*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 number of total essential blood vessels, 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 number of total essential blood vessels on MRCP and CT. The same analysis will be done for the hepatic arteries, hepatic veins, and focal liver lesions. 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
- Living Donor Liver Transplantation
- Being tested
- Living liver donors
- Keywords
- Liver Transplantation, Living Donor, Computed Tomography, Magnetic Resonance Imaging, 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 group | Role | What they receive |
|---|---|---|
| Living liver donors | The 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.
Essential blood vessels
The primary outcome is the number of total essential blood vessels including anatomical variations.
Measured: Preoperative during screening for living liver donation.
Secondary outcomes (2)
Hepatic arteries
The number of hepatic arteries including non-essential hepatic arteries.
Measured: Preoperative during screening for living liver donation.
Hepatic veins
The number of hepatic veins including non-essential hepatic veins.
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.
- First posted13 Mar 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Living Donor Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Minnee, Erasmus Medical Center
- Investigators
- Robert C. Minnee, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875232
- Sponsor's protocol ID
- MEC-2024-0779
- Acronym
- BVLDLT
- Status last verified
- Feb 2025
- First submitted
- 4 Mar 2025
- Last updated
- 13 Mar 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
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 38573086Vernuccio F, Whitney SA, Ravindra K, Marin D. CT and MR imaging evaluation of living liver donors. Abdom Radiol (NY). 2021 Jan;46(1):17-28. doi: 10.1007/s00261-019-02385-6.
PubMed 31901101Testa 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 35258132Yim 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 37565633Jackson 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between CT and MRCP Pre-LDLT for Liver Blood Vessel Assessment: an Ambidirectional Cohort Study
- ClinicalTrials.gov ID
- NCT06875232
- Acronym / sponsor ID
- BVLDLT / MEC-2024-0779
- Conditions
- Living Donor Liver Transplantation
- Keywords
- Liver Transplantation, Living Donor, Computed Tomography, Magnetic Resonance Imaging, Anatomy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Living donor liver transplantation (LDLT) is a good solution to the donor liver shortage in the Netherlands. In cases of severe liver disease, LDLT has substantial survival benefits, fewer (future) complications, and an improved quality of life.
Donor screening is extensive to minimize risks for both donors and recipients. The liver's blood vessels are assessed using CT and the bile ducts with MRCP. Blood vessel assessment can also be performed using MRCP, which would make the CT unnecessary. Before CT can be removed from the screening procedure, the correlation between blood vessel assessment on CT and MRCP must be clarified.
It is hypothesized that CT is equally adequate in assessing liver blood vessels to MRCP.
Detailed description
Research methods:
Data, CT-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 CT- and MRCP-images will be coded at random with different codes for the CT and MRCP of the same donor. These coded images will be shared with the radiologist through Castor. He will count the blood vessels and look for focal liver lesions. 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 blood vessel assessment on CT and MRCP will be thoroughly described.
The mean (Standard Deviation (SD)) number of total essential blood vessels will be calculated for CT and for MRCP. The correlations between CT and MRCP will be calculated by the following formula: (mean number on CT)/(mean number on MRCP)*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 number of total essential blood vessels, 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 number of total essential blood vessels on MRCP and CT. The same analysis will be done for the hepatic arteries, hepatic veins, and focal liver lesions. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living liver donors | – | Procedure: Living liver donorsThe population consists of adult living liver donors at the Erasmus MC. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population consists of adult living liver donors at the Erasmus MC.
Key inclusion criteria (8 listed)
- 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
- 18-60 years old
- Physical and mental well-being
Key exclusion criteria (16 listed)
- There are no exclusion criteria for this study.
- Absolute exclusion criteria
- Medical conditions (for instance heart disease and bleeding or clotting disorders)
- History of liver disease
- Previous/active malaria infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living liver donorsAdults who are screened for living liver donation. | Procedure or surgery | Living liver donors |
Primary outcome
Essential blood vessels
Time frame: Preoperative during screening for living liver donation.
The primary outcome is the number of total essential blood vessels including anatomical variations.
2 secondary outcomes
Hepatic arteries
Time frame: Preoperative during screening for living liver donation.
Hepatic veins
Time frame: Preoperative during screening for living liver donation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 38573086Ter 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.
- Background: PubMed 31901101Vernuccio F, Whitney SA, Ravindra K, Marin D. CT and MR imaging evaluation of living liver donors. Abdom Radiol (NY). 2021 Jan;46(1):17-28. doi: 10.1007/s00261-019-02385-6.
- Background: PubMed 35258132Testa 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.
- Background: PubMed 37565633Yim 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.
- Background: PubMed 35921119Jackson 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert C. Minnee, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
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 8 inclusion and 16 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 13 Mar 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?
Essential blood vessels (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 NCT06875232, which also lists 5 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 13 Mar 2025.