NCT02798861

Controlled Attenuation Parameter (CAP) in Liver Allografts

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Andres Duarte-Rojo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-07
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-06-14
• Last updated: 2020-07-31
• Results posted: 2020-07-31

Locations

3 sites across 1 country: United States