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

NCT ID: NCT04146636

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2020-11-26

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.

Conditions

NAFLD; Alcohol-Related Disorder; Liver Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic Test: e-LIFT

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

Group Type: OTHER

e-LIFT

Intervention Type: DIAGNOSTIC_TEST

Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and \< 15 kPa)

Interventions

e-LIFT

Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and \< 15 kPa)

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr Adrien LANNES

Angers, , France

Countries

France

Other Identifiers

2019-A01895-52

Identifier Type: -

Identifier Source: org_study_id