Clinical trial NCT02798861: Controlled Attenuation Parameter (CAP) in Liver Allografts
Official title: Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant
Liver Steatosis
Liver Disease
Primary Non-function
Early Allograft Dysfunction
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Allograft procured and transplanted into recipients.

Brief 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

Eligibility 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

Primary outcomes:
measure: Controlled Attenuation Parameter (CAP) - Accuracy
timeFrame: Baseline (pre-procurement) to 6 months post liver transplant
Secondary outcomes:
measure: LSM
timeFrame: Pretransplant to 6 months posttransplant
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Stanford
country: United States
facility: Stanford University
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: University of Pittsburgh
name: Andres Duarte-Rojo, MD
role: PRINCIPAL_INVESTIGATOR
References: