Controlled Attenuation Parameter (CAP) in Liver Allografts

Andres Duarte-Rojo

Status: Completed

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

Treatments: Device: Fibroscan 402/530

Study type: Observational

Funder types: Other

Identifiers

NCT02798861

204560

Details and patient eligibility

About

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 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

Enrollment: 160 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

160 participants in 1 patient group

CAP assessment

Description:

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

Treatment:

Device: Fibroscan 402/530