Controlled Attenuation Parameter (CAP) in Liver Allografts

Overview

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.

Full Title of Study: “Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 1, 2019

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

Interventions

  • Device: Fibroscan 402/530
    • Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Controlled Attenuation Parameter (CAP) – Accuracy
    • Time Frame: 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 Measures

  • LSM
    • Time Frame: Pretransplant to 6 months posttransplant
    • Liver stiffness measurement

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Andres Duarte-Rojo
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Andres Duarte-Rojo, Associate Professor – University of Pittsburgh
  • Overall Official(s)
    • Andres Duarte-Rojo, MD, Principal Investigator, University of Pittsburgh

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