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

NCT01784484 | Unknown DMC

• 1 other identifier: 0058-12-ZIV
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Liver Enzymes

Outcome Measures

Primary Outcomes (1)

• liver stiffness

  one year

Study Arms (1)

patients with abnormal liver enzymnes

Other: No intervention

Interventions

No intervention OTHER

patients with abnormal liver enzymnes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with abnormal liver enzymnes who attend the liver clinic

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assy Nimer: lead

Study Sites (1)

Ziv Medical Center

Safed, Israel, 13100, Israel

Location

Central Study Contacts

Nimer Assy, MD

CONTACT

+972-4-6828442; assy.n@ziv.health.gov.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Assy Nimer

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 5, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

IL (1)