Controlled Attenuation Parameter (CAP) in Liver Allografts

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.

Study Overview

• Status: Completed
• Conditions: Liver Disease; Early Allograft Dysfunction; Liver Steatosis; Liver Transplant; Primary Non-function
• Intervention / Treatment: Device: Fibroscan 402/530

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

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Allograft procured and transplanted into recipients.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Andres Duarte-Rojo

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: 204560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No