Trials / Completed
CompletedNCT04384159
Combination Diagnostic Strategies in NAFLD
Transient Versus Bidimensional Shear Wave Elastography in Serial Combination Strategy to Diagnose Advanced Fibrosis in NAFLD Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 577 (actual)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Serial combination of biological and elastography tests is accurate to diagnosing advanced fibrosis in non-alcoholic fatty liver disease (NAFLD) patients. In this study, the investigators compared the diagnostic performances of a 2-step strategy using either vibration-controlled transient elastography (VCTE) or bidimensional shear wave elastography with Supersonic imagine (2D-SWE-SSI), and analysed the added-value of a 3-step strategy.
Detailed description
The investigators retrospectively selected all consecutive adult patients with suspicion of NAFLD who had undergone liver biopsy from November 2011 to July 2019 in 2 French academic centers, Angers and Bordeaux university hospitals. A total of 577 patients were included. Among them, 291 had been previously included in a prospective study comparing diagnostic performances of several non-invasive tests in NAFLD patients. Inclusion criteria were: Age≥18yo, 2D-SWE-SSI and VCTE performed within the two weeks prior to liver biopsy. Exclusion criteria were high alcohol consumption (i.e., \>21 drinks, on average, per week in men and \>14 drinks, on average, per week in women), associated causes of liver disease (alcoholic, viral, or other causes of liver injury), other aetiologies than NAFLD on pathological examination, and a liver biopsy length of less than 10 mm and/or fewer than 6 portal spaces and/or more than 2 fragments, except for in cases of cirrhosis.
Conditions
Timeline
- Start date
- 2011-11-30
- Primary completion
- 2019-07-01
- Completion
- 2019-07-31
- First posted
- 2020-05-12
- Last updated
- 2020-05-12
Source: ClinicalTrials.gov record NCT04384159. Inclusion in this directory is not an endorsement.