Controlled Attenuation Parameter (CAP) in Liver Allografts

Liver Disease Clinical Trial

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

Status Completed

Clinical Trial Summary

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 at least 120 transplanted liver allografts.

Clinical Trial Description

This is a coordinated study utilizing 3 recruitment centers (University of Arkansas for Medical Sciences [UAMS], Stanford University, and Mayo Clinic) 2 liver pathology reading centers (University of Michigan and Mayo Clinic), and 1 coordinating center (University of Arkansas). The cohort study with a cross-sectional component for the primary aim has been completed (through independent Institutional Review Board [IRB] agreements) at UAMS, Stanford University, and the Mayo Clinic. The samples collected at the three recruitment centers will be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation. The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients. Criteria for recruitment are as follows:

Inclusion criteria - Liver Recipient

• Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor

• Valid TE with Fibroscan 530, defined as:

• At least 10 valid measurements

• Interquartile Range (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 ;

Related Conditions & MeSH terms

• Early Allograft Dysfunction
• Fatty Liver
• Liver Disease
• Liver Diseases
• Liver Steatosis
• Liver Transplant
• Primary Non-function

• NCT number: NCT02798861
• Study type: Observational
• Source: University of Pittsburgh
• Status: Completed
• Start date: September 7, 2016
• Completion date: June 1, 2019