Clinical trial NCT03608748: Early Detection of Advanced Fatty Liver Disease
Official title: Prospective Study: Early Detection of Advanced Fatty Liver Disease in the General Adult Population by Using Non-Alcoholic Fatty Liver Disease Score and Elastography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-alcoholic Fatty Liver Disease
Liver Fibrosis
Keywords: Nafld Score
Elastography
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Non-Alcoholic Fatty Liver Disease Score
timeFrame: Up to five minutes
Secondary outcomes:
measure: Elastography Test
timeFrame: Up to two hours
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center
Study officials:
affiliation: haemek medical center
name: Rawi Hazzan, Dr
role: PRINCIPAL_INVESTIGATOR
References: