Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)

University Hospital, Angers

Status: Completed

Conditions: Alcohol-Related Disorder; Liver Fibrosis; NAFLD

Treatments: Diagnostic Test: e-LIFT

Study type: Interventional

Funder types: Other

Identifiers

NCT04146636

2019-A01895-52

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 282 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NAFLD and/or alcoholic patient defined by ≥1 of the following criteria:

  • Excessive alcohol consumption: >210 g/week (men), >140 g/week (women)
  • Type 2 diabetes
  • ≥2 metabolic factors among: 1/BMI ≥25kg/m2; 2/elevated blood pressure (antihypertensive drug, or systolic blood pressure ≥130mmHg, or diastolic blood pressure ≥85mmHg), 3/dyslipidemia (lipid-lowering drug, or HDL cholesterol <40mg/dl (men) / <50mg/dl (women), or triglycerides ≥150mg/dl); 4/hyperferritinemia (>300 ng/ml (men)/>200 ng/ml (women))
  • Bright liver at ultrasonography without steatosis-inducing drug

• Obtaining the signature of the consent to participate in the study

Exclusion criteria

• 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
• Inadequate understanding of the French language
• Pregnant, breastfeeding or parturient women
• Persons deprived of their liberty by judicial or administrative decision
• Persons subject to legal protection measures
• Persons unable to consent
• Refusal to participate

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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282 participants in 1 patient group

Diagnostic Test: e-LIFT

Other group

Description:

only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference

Treatment:

Diagnostic Test: e-LIFT