Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors
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 at least 120 transplanted liver allografts.
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:
Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
Donation after circulatory death (DCD)
No liver biopsy obtained during organ procurement process
Inclusion criteria - Liver Recipient
Inclusion criteria - Liver Donor
Valid TE with Fibroscan 402/530, defined as:
Exclusion criteria - Liver Recipient
Exclusion criteria - Liver Donor