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Completed

NCT Number: NCT02798861

Controlled Attenuation Parameter (CAP) in Liver Allografts

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibroscan 402/530

Device

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

Primary outcomes

  1. 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 outcomes

  1. LSM

    Time frame: Pretransplant to 6 months posttransplant

    Liver stiffness measurement

Sponsors and collaborators

Lead sponsor

Andres Duarte-Rojo

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2016
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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