Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Diseases
- Sponsor
- Prof. Ziv Ben-Ari MD
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Liver Biopsy Result for liver fibrosis grade
- Last Updated
- 8 years ago
Overview
Brief Summary
This study evaluates the ability of Magnetic Resonance Elastography non invasive technology to identify the liver fibrosis stage in patients with chronic liver diseases compared to Shear Wave Elastography and/or Liver Biopsy.
Detailed Description
Recent advances in magnetic resonance imaging (MRI) of the liver have led to improvements in diagnosis of chronic liver diseases. Detection and staging of liver fibrosis has become important; however, until about the last decade, it depended on an invasive liver biopsy. Liver biopsy is limited by high cost, low patient acceptance, interobserver variability during microscopic evaluation, sampling error, poor reproducibility, and, importantly, an invasive nature with a complication rate of 3% and a mortality rate of 0.03%. With the emergence of elastography techniques, the need for liver biopsy has rapidly diminished for diagnosis of clinically significant liver fibrosis. Magnetic Resonance Elastography has gained increasing popularity in recent years, in large part due to its higher technical success and ability to overcome some of the weaknesses of ultrasound-based methods for assessing liver fibrosis.
Investigators
Prof. Ziv Ben-Ari MD
Head of Liver Diseases Center
Sheba Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients with chronic liver diseases
Exclusion Criteria
- •Patients who don't have chronic liver diseases
Outcomes
Primary Outcomes
Liver Biopsy Result for liver fibrosis grade
Time Frame: Patient will undergo Liver biopsy once during 1 year of the study.
Liver Fibrosis score measured by Metavir scale .The Metavir score grades the degree of fibrosis on a 5-point scale from 0 to 4. The activity, which is the amount of inflammation (specifically, the intensity of necro-inflammatory lesions), is graded on a 4-point scale from A0 to A3. Fibrosis score: F0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis Activity score: A0 = no activity A1 = mild activity A2 = moderate activity A3 = severe activity Liver biopsy will be perfomed only according to physician recommendation.
Magnetic Resonance Elastography (MRE) Result for liver fibrosis grade
Time Frame: Patient will undergo Magnetic Resonance Elastography (MRE) once during 1 year of the study.
Liver Fibrosis score determined by liver stiffness in 4 fibrosis grades: \>1=any fibrosis, \>2=significant fibrosis, \>3=advanced fibrosis, 4=cirrhosis
Shear Wave Elastography Result for liver fibrosis grade
Time Frame: Patient will undergo Shear Wave Elastography once during 1 year of the study.
Liver Fibrosis score determined by liver stiffness in in 5 fibrosis grades: 0=no fibrosis, \>1=any fibrosis, \>2=significant fibrosis, \>3=advanced fibrosis, 4=cirrhosis