Combination Diagnostic Strategies in NAFLD
- Conditions
- Chronic Liver DiseaseNon-Alcoholic Fatty Liver Disease
- Registration Number
- NCT04384159
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 577
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracyclassification 1 day Diagnostic accuracyclassification
- Secondary Outcome Measures
Name Time Method