Dr Adrien LANNES
Angers, 49933, France
NCT Number: NCT04146636
The main objective is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.
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Notify Me40 year–75 year
All sexes
Interventional
Not applicable
Angers, 49933, France
eLIFT, is a new blood fibrosis test specifically dedicated for general practitioners with simple parameters and easy "by head" calculation. Using the recommended cut-offs (eLIFT ≥8), eLIFT sensitivity was 86%. This result position eLIFT an as interesting tool for the screening of advanced liver fibrosis in large populations.
As our preliminary results come from very selected patients, i.e. patients from tertiary centres who underwent a liver biopsy, we now need to evaluate in the real condition of primary care setting whether the use of eLIFT will help general practitioners to screen advanced liver fibrosis in their asymptomatic NAFLD and alcoholic patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa)
Time frame: 1 day
The primary outcome of the study is the negative predictive value for the diagnosis of advanced hepatic fibrosis (i.e., the rate of patients who do not actually have advanced hepatic fibrosis when the eLIFT test is <8)
Time frame: 1 day
Rate of patients with an eLIFT test ≥8 among patients with advanced hepatic fibrosis
Time frame: 1 day
Rate of patients with an eLIFT test ≥8 but without a final diagnosis of advanced hepatic fibrosis (false positives), specificity (i. e. the rate of patients with an eLIFT test < 8 among patients without advanced hepatic fibrosis) and positive predictive value of the eLIFT test (i. e. the rate of patients with effective advanced hepatic fibrosis when the eLIFT test is ≥ 8)
Time frame: 1 day
Rate of patients with hepatocellular carcinoma (diagnosed by recommended radiological criteria or liver biopsy); rate of patients with gastroesophageal varices at risk of bleeding diagnosed by gastrointestinal endoscopy (according to Baveno VI rules: medium to large or small varices with red signs) among patients with an eLIFT test is ≥ 8
Time frame: 1 day
Rates of patients with advanced hepatic fibrosis, hepatocellular carcinoma rate, gastroesophageal varicose vein rate at risk of bleeding, eLIFT test rate ≥8, sensitivity, specificity, negative predictive value, positive predictive value in each subgroup (NAFLD, alcohol and NAFLD + alcohol)
University Hospital, Angers
Other Gov
Acronym: IMPROVE
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