Controlled Attenuation Parameter (CAP) in Liver Allografts

Completed

Conditions: Early Allograft Dysfunction
Liver Transplant
Liver Disease
Liver Steatosis
Primary Non-function

Brief 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.

Detailed 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

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
CAP assessment	Fibroscan 402/530	Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes

Primary Outcome Measures

Name	Time	Method
Controlled Attenuation Parameter (CAP) - Accuracy	Baseline (pre-procurement) to 6 months post liver transplant	CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference

Secondary Outcome Measures

Name	Time	Method
LSM	Pretransplant to 6 months posttransplant	Liver stiffness measurement

Locations (3): Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Stanford University
🇺🇸
Stanford, California, United States
University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States