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Real Time Elastography in Liver Fibrosis (RT-ELASTO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by University of Medicine and Pharmacy Craiova.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
University of Medicine and Pharmacy "Victor Babes" Timisoara
Information provided by (Responsible Party):
Dan Gheonea, University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier:
NCT01948687
First received: September 3, 2013
Last updated: September 18, 2013
Last verified: September 2013
  Purpose
AIM To evaluate the role of real time elastography (ARFI and Hitachi elastography) in noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis

Condition
Cirrhosis
Chronic Liver Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Role of Real Time Elastography in the Noninvasive Assessment of Liver Fibrosis in Chronic Viral Hepatitis

Resource links provided by NLM:


Further study details as provided by University of Medicine and Pharmacy Craiova:

Primary Outcome Measures:
  • Real Time Elastography result [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Value of real time elastography recordings for the evaluation of liver fibrosis.


Estimated Enrollment: 500
Study Start Date: August 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1. the control group
healthy adult volunteers
2. patients with chronic hepatitis
patients with chronic hepatitis B or C (defined by the presence of serum anti hepatitis C antibody or serum hepatitis B surface antigen)
3. liver cirrhosis type B or C
patients with liver cirrhosis type B or C

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948687

Locations
Romania
Researche Center of Gastroenterology and Hepatology
Craiova, Dolj, Romania, 200635
University of Medicine and Pharmacy
Timisoara, Timis, Romania, 200635
Sponsors and Collaborators
University of Medicine and Pharmacy Craiova
University of Medicine and Pharmacy "Victor Babes" Timisoara
Investigators
Principal Investigator: Adrian Saftoiu, MD, PhD UMF Craiova
  More Information

Publications:
1. Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008; 48: 835-847. 2. V de Lédinghen, Vergniol J, Foucher J, El-Hajbi F, Merrouche W, Rigalleau V. Feasibility of liver transient elastography with FibroScan using a new probe for obese patients. Liver Int. 2010 Aug; 30 (7): 1043-8. 3. Friedrich-Rust M, Nierhoff J, Lupsor M, et al. Performance of Acoustic Radiation Force Impulse imaging for the staging of liver fibrosis: a pooled meta-analysis. J Viral Hepat. 2012 Feb; 19 (2): 212-9. 4. Koizumi Y, Hirooka M, Kisaka Y et al. Liver fibrosis in patients with chronic hepatitis C: noninvasive diagnosis by means of real-time tissue elastography--establishment of the method for measurement. Radiology. 2011; 258: 610-617. 5. Gheonea DI, Săftoiu A, Ciurea T et al. Real-time sono-elastography in the diagnosis of diffuse liver diseases. World J Gastroenterol. 2010; 16: 1720-1726.

Responsible Party: Dan Gheonea, MD, PhD, MSc Specialist in Gastroenterology, University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier: NCT01948687     History of Changes
Other Study ID Numbers: RT-ELASTO 
Study First Received: September 3, 2013
Last Updated: September 18, 2013
Health Authority: Romania: National Authority for Scientific Research

Keywords provided by University of Medicine and Pharmacy Craiova:
real time elastography
hepatitis

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Digestive System Diseases

ClinicalTrials.gov processed this record on December 02, 2016