Status:
UNKNOWN
The Role of Strain Elastography in Staging Liver Fibrosis
Lead Sponsor:
University of Medicine and Pharmacy Craiova
Collaborating Sponsors:
University of Medicine and Pharmacy "Victor Babes" Timisoara
Conditions:
Cirrhosis
Chronic Liver Disease
Eligibility:
All Genders
18-70 years
Brief Summary
AIM: To evaluate the role of Strain Elastography in the assessment of liver fibrosis in chronic hepatopathy
Detailed Description
INTRODUCTION Establishing liver fibrosis grade in patients with chronic viral hepatitis is very important for the prognostic assessment and in making the decision to initiate antiviral treatment. Alt...
Eligibility Criteria
Inclusion
- age over 18 years old
- Study will include three groups of patients as follows:
- Group I: patients with chronic hepatitis B or C (defined by the presence of serum anti HCV antibody or serum hepatitis B surface antibody)
- Group II (the control group): healthy adult volunteers
- Group III: patients with hepatic cirrhosis type B or C
- There at least one reference method available for patients with chronic hepatitis (Transient elastography/ liver biopsy)
- Hepatic cirrhosis diagnosis is established using clinical and paraclinical features (ultrasonography, superior digestive endoscopy)
- A written informed consent is given to each patient
Exclusion
- Patients with contraindication for elastography (pregnant women or who are breastfeeding) and patients with pacemakers
- Patients with liver disease of other etiology than viral infection (autoimmune hepatitis, primary biliary hepatitis, primary sclerosing cholangitis, hemochromatosis, alfa 1-antitrypsin deficiency, or Wilson's disease)
- History of alcohol abuse (alcohol intake\> 20g/day)
- Patients under treatment with hepatotoxic drugs (methotrexate, amiodarone, corticotherapy , chemotherapy, hormonotherapy)
- Patients with technically unfeasible TE: patients with ascites
Key Trial Info
Start Date :
March 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02184000
Start Date
March 1 2014
End Date
September 1 2014
Last Update
July 8 2014
Active Locations (2)
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1
Researche Center of Gastroenterology and Hepatology
Craiova, Dolj, Romania, 200635
2
University of Medicine and Pharmacy
Timișoara, Timiș County, Romania, 200635