Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity Hospital, Angers
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Already ongoing specialized follow-up for a chronic liver disease
Altered health status with poor short-term prognosis, not compatible with a screening procedure
Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
Acute infection
Trial design
Treatments tested in this trial
- eLIFT
Treatment groups
1,788 Participants
are divided into 1 treatment groupLocations
13ANGERS49000, Angers France
CHU Angers49000, Angers France
BAUGE49150, Baugé-en-Anjou France
BECON49370, Bécon-les-Granits France
Sponsors and collaborators
University Hospital, Angers
Lead sponsor
Source ClinicalTrials.gov