Controlled Attenuation Parameter (CAP) in Liver Allografts

Status:	Enrolling by invitation
Conditions:	Gastrointestinal, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 80
Updated:	3/28/2019
Start Date:	September 7, 2016
End Date:	December 2019

Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors

The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis
using liver biopsies as reference. Secondarily, investigators will correlate transient
elastography (TE) and CAP results, analyze possible associations between CAP/TE and
post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The
study aims to include as many donors as needed to achieve 100 transplanted liver allografts.

Inclusion criteria - Liver Recipient

- Men and women, Age 18-years old to 80-years old inclusive

Inclusion criteria - Liver Donor

- Valid TE with Fibroscan 402/530, defined as:

- At least 10 valid measurements

- IQR/Median stiffness value <30% (only in cases with >7.1 kPa)

Exclusion criteria - Liver Recipient

- Patient did not undergo liver transplantation

Exclusion criteria - Liver Donor

- Donation after circulatory death (DCD)

- No liver biopsy obtained during organ procurement process

We found this trial at

sites

University of Arkansas for Medical Sciences

529 West Markham Street
Little Rock, Arkansas 72205

(501) 686-7000