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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Test: e-LIFT | Other | only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-LIFT | Diagnostic Test | Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa) |
|
| Measure | Description | Time Frame |
|---|---|---|
| e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis | 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) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| sensibility of the eLIFT test | Rate of patients with an eLIFT test ≥8 among patients with advanced hepatic fibrosis | 1 day |
| specificity and positive predictive value of the eLIFT test | 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) |
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Inclusion Criteria:
NAFLD and/or alcoholic patient defined by ≥1 of the following criteria:
Obtaining the signature of the consent to participate in the study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Adrien LANNES | Angers | 49933 | France |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D019973 | Alcohol-Related Disorders |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D019966 | Substance-Related Disorders |
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prospective diagnostic study in primary care. Evaluation of a simple blood test (e-LIFT) for the diagnosis of advanced liver fibrosis.
Reference for advanced liver diagnosis : composite criteria :
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| 1 day |
| rate of liver complications among patients with an eLIFT test ≥ 8 | 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 | 1 day |
| performance of e-LIFT test in subgroup analysis | 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) | 1 day |
| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |