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

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ClinicalTrials.gov Identifier: NCT01784484
Recruitment Status : Unknown
Verified February 2013 by Assy Nimer, Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 5, 2013
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Assy Nimer, Ziv Hospital

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.

Condition or disease Intervention/treatment
Elevated Liver Enzymes Other: No intervention

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Study Type : Observational
Time Perspective: Prospective
Official Title: Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes
Study Start Date : February 2013
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

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



Primary Outcome Measures :
  1. liver stiffness [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with abnormal liver enzymnes who attend the liver clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784484


Contacts
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Contact: Nimer Assy, MD +972-4-6828442 assy.n@ziv.health.gov.il

Locations
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Israel
Ziv Medical Center Not yet recruiting
Safed, Israel, 13100
Contact: Nimer Assy, MD    +972-4-6828442    assy.n@ziv.health.gov.il   
Sponsors and Collaborators
Assy Nimer

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Responsible Party: Assy Nimer, Prof. Assy Nimer, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01784484     History of Changes
Other Study ID Numbers: 0058-12-ZIV
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases