Controlled Attenuation Parameter (CAP) in Liver Allografts

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Device: Fibroscan 402/530


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAP assessment<br>Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes | Device: Fibroscan 402/530<br>* Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LSM | Liver stiffness measurement | Pretransplant to 6 months posttransplant |