Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

Fatty Liver Clinical Trial

Official title:

Pilot Study for the Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02873507
• Other study ID #: 160152
• Status: Withdrawn
• Phase: N/A
• First received: August 4, 2016
• Last updated: January 31, 2018
• Start date: May 2018
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients who are scheduled to orthoptic liver transplant

Exclusion Criteria:

• Patient's who do not agree to sign consent

Related Conditions & MeSH terms

• Fatty Liver
• Steatosis of Liver

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation	Amount of fat measured in the donor liver prior to transplant surgery using MRI scan	Measured immediately prior to liver transplant
Secondary	Comparison of steatosis percentages provided by biopsy to MRI results		Baseline
Secondary	Length of hospitalization of transplant recipient		Days to hospital discharge, approximately 2 weeks
Secondary	Mortality of liver transplant recipient at 1 year post transplantation		1 year