Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes

BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in chronic hepatitis C, however limited data are available in chronic hepatitis B and in non alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are being followed up in the liver unit and to find associated factors with significant fibrosis and cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values will emerge as the most important independent predictive variable of fibrosis and not serum ALT. A significant correlations between soft drink and coffee consumption with the extent of liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that screening patients with elevated liver enzymes is beneficial and detect earlier the presence of liver fibrosis mainly in patients with NAFLD.

Study Overview

• Status: Unknown
• Conditions: Elevated Liver Enzymes
• Intervention / Treatment: Other: No intervention

• Study Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Safed, Israel, 13100
    • Ziv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with abnormal liver enzymnes who attend the liver clinic

Description

Inclusion Criteria:

• Male or female subjects
• More than 18 years of age
• Patients with elevated liver enzymes
• Written informed consent

Exclusion Criteria:

• Patients refusing to participate to the study and to provide written informed consent
• clotting disorder
• ongoing treatment with anti-coagulant or anti-aggregant
• advanced or decompensated cirrhosis (Child-Pugh class C)
• hepatocellular carcinoma
• other cancer
• history of surgery for brain aneurysm
• pace maker or defibrillator
• ocular metal foreign body

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with abnormal liver enzymnes	Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
liver stiffness	one year

Collaborators and Investigators

• Sponsor: Assy Nimer

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: February 3, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 3, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 0058-12-ZIV