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

NAFLD Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146636
• Other study ID #: 2019-A01895-52
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: November 26, 2020

Study information

• Verified date: May 2022
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: November 26, 2020
• Est. primary completion date: September 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol-Related Disorder
• Alcohol-Related Disorders
• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
France	Dr Adrien LANNES	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis	The primary outcome of the study is the negative predictive value for the diagnosis of advanced hepatic fibrosis (i.e., the rate of patients who do not actually have advanced hepatic fibrosis when the eLIFT test is <8)	1 day
Secondary	sensibility of the eLIFT test	Rate of patients with an eLIFT test =8 among patients with advanced hepatic fibrosis	1 day
Secondary	specificity and positive predictive value of the eLIFT test	Rate of patients with an eLIFT test =8 but without a final diagnosis of advanced hepatic fibrosis (false positives), specificity (i. e. the rate of patients with an eLIFT test < 8 among patients without advanced hepatic fibrosis) and positive predictive value of the eLIFT test (i. e. the rate of patients with effective advanced hepatic fibrosis when the eLIFT test is = 8)	1 day
Secondary	rate of liver complications among patients with an eLIFT test = 8	Rate of patients with hepatocellular carcinoma (diagnosed by recommended radiological criteria or liver biopsy); rate of patients with gastroesophageal varices at risk of bleeding diagnosed by gastrointestinal endoscopy (according to Baveno VI rules: medium to large or small varices with red signs) among patients with an eLIFT test is = 8	1 day
Secondary	performance of e-LIFT test in subgroup analysis	Rates of patients with advanced hepatic fibrosis, hepatocellular carcinoma rate, gastroesophageal varicose vein rate at risk of bleeding, eLIFT test rate =8, sensitivity, specificity, negative predictive value, positive predictive value in each subgroup (NAFLD, alcohol and NAFLD + alcohol)	1 day