Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.
• NAFLD and/or ALD patient defined by at least 1 of the following criteria:
‣ Excessive alcohol consumption: higher than 210 g / week (men), or 140 g / week (women)
⁃ Type 2 diabetes
⁃ at least 2 metabolic factors among BMI higher than or equal to 25 kg / m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg/dl (men) / 50mg/dl (women), or triglycerides higher than or equal to150mg/dl); Hyperferritinemia (higher than upper limit of normal from the laboratory)
⁃ Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)
∙ Following a protocol amendment, the 3 last investigating primary care centres will include NAFLD and/or ALD patients according to these updated criteria:
• Excessive alcohol consumption: \>210 g/week in men or \>140 g/week in women,
• AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments,
• AND with the following stratification:
• 30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments)
• Patient's agreement to have a blood sample collected in a local laboratory participating in the study
• Subjects covered by or having the rights to medical care assurance
• Written informed consent obtained from subject