The Role of Strain Elastography in Staging Liver Fibrosis (SELF)
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ClinicalTrials.gov Identifier: NCT02184000
Recruitment Status : Unknown
Verified June 2014 by Dan Gheonea, University of Medicine and Pharmacy Craiova. Recruitment status was: Recruiting
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
University of Medicine and Pharmacy Craiova
University of Medicine and Pharmacy "Victor Babes" Timisoara
Information provided by (Responsible Party):
Dan Gheonea, University of Medicine and Pharmacy Craiova
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The patients included in the study will be healthy voluntaries, patients with chronic hepatitis B or C and patients with liver cirrhosis. ARFI and Hitachi elastography will be performed for each patient and the results will be compared with final diagnosis. The final diagnosis (the stage) will be established based on Transient elastography and or liver biopsy.
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
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