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

• Conditions: Elevated Liver Enzymes
• Interventions: Other: No intervention

• Registration Number: NCT01784484
• Lead Sponsor: Assy Nimer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-23
• Status Verified: 2013-02
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-03
• Last Update Submitted: 2013-02-03
• Study First Posted: 2013-02-05
• Last Update Posted: 2013-02-05
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with abnormal liver enzymnes	No intervention	-

Primary Outcome Measures

Name	Time	Method
liver stiffness	one year

Trial Locations

Locations (1)

Ziv Medical Center; 🇮🇱 Safed, Israel