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

NCT ID: NCT01784484

Last Updated: 2013-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Brief Summary

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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

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Conditions

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Elevated Liver Enzymes

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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patients with abnormal liver enzymnes

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assy Nimer

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assy Nimer

Prof. Assy Nimer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ziv Medical Center

Safed, Israel, Israel

Site Status

Countries

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Israel

Central Contacts

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Nimer Assy, MD

Role: CONTACT

+972-4-6828442

Facility Contacts

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Nimer Assy, MD

Role: primary

+972-4-6828442

Other Identifiers

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0058-12-ZIV

Identifier Type: -

Identifier Source: org_study_id

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