Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

Overview

A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room.

Full Title of Study: “Pilot Study for the Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

Detailed Description

The images from MRI will be analyzed to obtain information of fat content in all eight segments of the liver. Demographic, intra-operative, and post-operative patient data will be collected for each imaged graft.

Interventions

  • Other: MRI of donor liver prior to transplant
    • MRI of the on ice donor liver within the transport cooler on its way to the operating room

Arms, Groups and Cohorts

  • Experimental: MRI of donor liver
    • MRI evaluation of graft steatosis in donor liver prior to transplantation

Clinical Trial Outcome Measures

Primary Measures

  • Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation
    • Time Frame: Measured immediately prior to liver transplant
    • Amount of fat measured in the donor liver prior to transplant surgery using MRI scan

Secondary Measures

  • Comparison of steatosis percentages provided by biopsy to MRI results
    • Time Frame: Baseline
  • Length of hospitalization of transplant recipient
    • Time Frame: Days to hospital discharge, approximately 2 weeks
  • Mortality of liver transplant recipient at 1 year post transplantation
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who are scheduled to orthoptic liver transplant Exclusion Criteria:

  • Patient's who do not agree to sign consent

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bret Alvis, Assistant Professor – Vanderbilt University Medical Center
  • Overall Official(s)
    • Bret D Alvis, M.D., Principal Investigator, Vanderbilt University Medical Center

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