CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
Fibroscan 402/530device
Likely dose
Fibroscan 402/530 obtained before procurement in donor and 1–3 months post-transplant in recipientAI-extracted
Key inclusion· 3
  • Age 18–80 years (liver recipient)
  • Valid Fibroscan 402/530 with ≥10 measurements and IQR/Median stiffness <30% (if >7.1 kPa)
  • Liver recipient must have undergone transplantation
Key exclusion· 2
  • Donation after circulatory death (DCD)
  • No liver biopsy obtained during organ procurement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02798861
NCT02798861N/ACompleted

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

Andres Duarte-Rojo·observational·Posted Jun 14, 2016·Updated Jul 31, 2020

In Brief

An observational study evaluating Fibroscan 402/530 for Liver Transplant and 4 related conditions. Completed, enrolled 160 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2016
Enrollment StartSep 7, 2016
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.0 years ago

Interventions

Fibroscan 402/530device

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