Controlled Attenuation Parameter (CAP) in Liver Allografts

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-07

Study Completion Date

2019-06-01

Brief Summary

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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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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CAP assessment

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

Fibroscan 402/530

Intervention Type DEVICE

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

Interventions

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Fibroscan 402/530

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women, Age 18-years old to 80-years old inclusive

* 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)