The Correlation Between CT and MRCP Before Living Liver Donation for Liver Blood Vessel Assessment: an Ambidirectional Cohort Study

NCT06875232 | Enrolling By Invitation DMC

• 1 other identifier: MEC-2024-0779
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Living Donor Liver Transplantation

Keywords

Liver Transplantation; Living Donor; Computed Tomography; Magnetic Resonance Imaging; Anatomy

Outcome Measures

Primary Outcomes (1)

• Essential blood vessels

  The primary outcome is the number of total essential blood vessels including anatomical variations.

  Preoperative during screening for living liver donation.

Secondary Outcomes (2)

• Hepatic arteries

  Preoperative during screening for living liver donation.

• Hepatic veins

  Preoperative during screening for living liver donation.

Other Outcomes (1)

• Focal liver lesions

  Preoperative during screening for living liver donation.

Study Arms (1)

Living liver donors

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

Procedure: Living liver donors

Interventions

Living liver donors PROCEDURE

Adults who are screened for living liver donation.

Living liver donors

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

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:
• 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:

• 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
• BMI \>33 kg/m2
• Smoking

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 38573086 BACKGROUND

• Vernuccio 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.

  PMID: 31901101 BACKGROUND

• 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.

  PMID: 35258132 BACKGROUND

• 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.

  PMID: 37565633 BACKGROUND

• 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.

  PMID: 35921119 BACKGROUND

Study Officials

• Robert C. Minnee, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 13, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: (Underlying) data will be made available alongside with the publication. It will be available for 10 years. Access to the data and images is approved by the head of department and principal investigator. This access is temporarily. To whom and when access approved is registered.
• Access Criteria: The PI will verify the authenticity of the requesting researcher and will check whether their intentions are in line with the informed consent and whether the intended methodology is suitable and will approve the request before providing access to the data. Other researchers could express their interest in the dataset through countersigned DTA. After meeting the sharing and reuse conditions as described above and approval of the PI, data access will be provided through the data repository.

Locations

NL (1)