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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT01948687
Date of registration:	03/09/2013
Prospective Registration:	No
Primary sponsor:	University of Medicine and Pharmacy Craiova
Public title:	Real Time Elastography in Liver Fibrosis RT-ELASTO
Scientific title:	The Role of Real Time Elastography in the Noninvasive Assessment of Liver Fibrosis in Chronic Viral Hepatitis
Date of first enrolment:	August 2013
Target sample size:	500
Recruitment status:	Recruiting
URL:	http://clinicaltrials.gov/show/NCT01948687
Study type:	Observational
Study design:	Observational Model: Case-Only, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Romania

Contacts

Name:	Larisa D Sandulescu, MD, PhD
Address:
Telephone:	+40723968354
Email:	larisasandulescu@yahoo.com
Affiliation:

Name:	Adrian Saftoiu, MD, PhD
Address:
Telephone:
Email:
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: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Liver Disease

Cirrhosis

Intervention(s)

Primary Outcome(s)

Real Time Elastography result [Time Frame: up to 24 weeks]

Secondary Outcome(s)

Secondary ID(s)

RT-ELASTO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UNIVERSITY OF MEDICINE AND PHARMACY TIMISOARA

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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