Fibroscan 402/530
DeviceFibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.
NCT Number: NCT02798861
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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Notify Me18 year–80 year
All sexes
Observational
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Liver Recipient
Inclusion criteria
- Liver Donor
Exclusion criteria
- Liver Recipient
Exclusion criteria
- Liver Donor
Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.
Time frame: Baseline (pre-procurement) to 6 months post liver transplant
CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference
Time frame: Pretransplant to 6 months posttransplant
Liver stiffness measurement
Andres Duarte-Rojo
Other
Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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