Clinical trial NCT04146636: Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
Official title: Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Alcohol-Related Disorder
Liver Fibrosis
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-10-31
Enrollment: 282
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 :

* Elastometry between 8 kPa and 15 kPa and histologic evaluation of fibrosis ≥ F3 (NASH CRN ) OR
* Elastometry ≥ 15 kPa
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis
timeFrame: 1 day
Secondary outcomes:
measure: sensibility of the eLIFT test
timeFrame: 1 day
measure: specificity and positive predictive value of the eLIFT test
timeFrame: 1 day
measure: rate of liver complications among patients with an eLIFT test ≥ 8
timeFrame: 1 day
measure: performance of e-LIFT test in subgroup analysis
timeFrame: 1 day
Other outcomes:
Locations:
city: Angers
country: France
facility: Dr Adrien LANNES
Study officials:
References: