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

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Completed
• CT.gov ID: NCT04146636
• Collaborator: (none)
• Enrollment: 282
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.6
• Patients Per Site Per Month: 24.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NAFLD; Alcohol-Related Disorder; Liver Fibrosis	Diagnostic Test: e-LIFT	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 282 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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 kPaprospective 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
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
• Actual Study Start Date: Dec 9, 2019
• Actual Primary Completion Date: Sep 8, 2020
• Actual Study Completion Date: Nov 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Diagnostic Test: e-LIFT only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference	Diagnostic Test: e-LIFT; Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa)

Outcome Measures

Primary Outcome Measures

1. e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis [1 day]

   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)

Secondary Outcome Measures

1. sensibility of the eLIFT test [1 day]

   Rate of patients with an eLIFT test ≥8 among patients with advanced hepatic fibrosis

2. specificity and positive predictive value of the eLIFT test [1 day]

   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)

3. rate of liver complications among patients with an eLIFT test ≥ 8 [1 day]

   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

4. performance of e-LIFT test in subgroup analysis [1 day]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Adrien LANNES	Angers		France	49933

Sponsors and Collaborators

• University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT04146636
• Other Study ID Numbers: 2019-A01895-52
• First Posted: Oct 31, 2019
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis; Alcohol-Related Disorders

Study Results

No Results Posted as of May 18, 2022