Early Detection of Advanced Fatty Liver Disease

Prospective Study: Early Detection of Advanced Fatty Liver Disease in the General Adult Population by Using Non-Alcoholic Fatty Liver Disease Score and Elastography

Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects.

The investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not monitored.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease; Liver Fibrosis

Detailed Description

The investigators will run an algorithm for the non-invasive diagnosis of advanced fibrosis in non-alcoholic fatty liver disease on a participants without known liver disease.

Nafld Score and Elastography are now being used to predict the severity of liver fibrosis and deciding whether the patient is going to a biopsy, clinical follow-up or further investigation of liver cirrhosis and complications.

The detection of participants with Nafld Score more than 0.675 (advanced fibrosis) will enroll them to an elastography test. Participants with advanced fibrosis according to elastography will be introduced to follow-up and treatment that should delay or prevent progression of the disease to more advanced conditions like: cirrhosis, portal hypertension, esophageal varicose veins and hepatocellular carcinoma.

If the investigators find that the results of the study are consistent with their hypothesis, this will lead to applying the flowchart to a larger sample of population in order to use it as a future survey.

Moreover, the investigators will check whether there is a correlation between Nafld Score and elastography in participants without know liver disease with Nafld Score more than 0.675.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

• Study Contact: Name: Rawi Hazzan, Dr; Phone Number: +97246495169; Email: ravih@clalit.org.il
• Study Contact Backup: Name: Habib Abu Shqara, Dr; Phone Number: +972544244590; Email: habiba_b@clalit.org.il

Study Locations

• Israel
  • Afula, Israel, 1834111
    • Haemek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All patients aged 45-60 years old without known liver disease who belong to an initial clinic which was chosen arbitrarily.

Description

Inclusion Criteria:

1. Subjects aged 45-60 who belong to an initial clinic which was chosen arbitrarily.
2. Subjects without known liver disease.
3. Subjects agree to sign a consent form. -

Exclusion Criteria:

1. History of right-sided heart failure
2. History of liver disease including positive infectious serology for hepatitis B or C
3. Pregnant women
4. People incapable of judgment -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Alcoholic Fatty Liver Disease Score	Non-alcoholic fatty liver disease Score (Nafld Score) is a non-invasive scoring system based on several laboratory tests that helps to estimate the amount of scarring in the liver. The score is made up of six parameters: age, BMI(body mass index), aspartate aminotransferase(AST) / alanine transaminase(ALT), platelet count, impaired fasting glucose(IFG), albumin. The Nafld Score formula is: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×10^9/l) - 0.66 × albumin (g/dl). 2 cutoff points were selected to identify the presence (> 0.675) and absence (< -1.455) of significant fibrosis. < -1.455: predictor of absence of significant fibrosis (F0-F2 fibrosis), negative predictive value 93% . between -1.455 and 0.675: indeterminate score. >0.675: predictor of presence of significant fibrosis (F3-F4 fibrosis), positive predictive value of 90%. The score will be calculated for all the participants.	Up to five minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elastography Test	Ultrasound Elastography is a non-invasive test which uses the technology of Shear Wave Elastography (SWE) obtained from the right liver lobe for staging liver fibrosis according to Metavir Fibrosis Score with sensitivity between 86% -98% and specificity between 90% -93%. Metavir Fibrosis Score is a system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy. Liver fibrosis assessed by Shear Wave Elastography is well correlated to biopsy using Metavir Score. Participants with Nafld Score above 0.675 will undergo ShearWave Elastography. The outcome of the test will be correlated to Metavir Score system according to the chart below: SWE (kiloPascal) , METAVIR score, Fibrosis Level. Below 5 , F0 , No fibrosis. 5.0-7.1 , F1 , Mild Fibrosis. 7.1-8.7 , F2 , Significant Fibrosis. 8.7-10.4 , F3 , Sever Fibrosis. 10.4-19 , F4 , Cirrhosis.	Up to two hours

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: Rawi Hazzan, Dr, Haemek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: July 8, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Elastography; Nafld Score
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 007-18-EMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No