Controlled Attenuation Parameter (CAP) in Liver Allografts

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798861
• Other study ID #: 204560
• Status: Completed
• Start date: September 7, 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Allograft Dysfunction
• Fatty Liver
• Liver Disease
• Liver Diseases
• Liver Steatosis
• Liver Transplant
• Primary Non-function

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Mayo Clinic	Rochester	Minnesota
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Andres Duarte-Rojo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	LSM	Liver stiffness measurement	Pretransplant to 6 months posttransplant