The Role of Strain Elastography in Staging Liver Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02184000
• Date of registration: 02/07/2014
• Prospective Registration: No
• Primary sponsor: University of Medicine and Pharmacy Craiova
• Public title: The Role of Strain Elastography in Staging Liver Fibrosis SELF
• Scientific title: Usefulness of the Strain Elastography in the Assessment of Liver Fibrosis in Chronic Hepatopathy
• Date of first enrolment: March 2014
• Target sample size: 500
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02184000
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Romania

Contacts

• Name: Larisa SANDULESCU, MD, PhD

• Name: Adrian Saftoiu, MD, PhD
• Affiliation: UMF Craiova

Key inclusion & exclusion criteria

Inclusion Criteria:

- age over 18 years old

- Study will include three groups of patients as follows:

1. Group I: patients with chronic hepatitis B or C (defined by the presence of
serum anti HCV antibody or serum hepatitis B surface antibody)

2. Group II (the control group): healthy adult volunteers

3. 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Liver Disease

Cirrhosis

Primary Outcome(s)

Strain Elastography results [Time Frame: up to 24 weeks]

Secondary ID(s)

Real-Time Elasto

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UNIVERSITY OF MEDICINE AND PHARMACY TIMISOARA