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Real Time Elastography in Liver Fibrosis (RT-ELASTO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Medicine and Pharmacy Craiova
Sponsor:
Collaborator:
UNIVERSITY OF MEDICINE AND PHARMACY 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
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

Contacts
Contact: Larisa D Sandulescu, MD, PhD +40723968354 larisasandulescu@yahoo.com

Locations
Romania
Researche Center of Gastroenterology and Hepatology Recruiting
Craiova, Dolj, Romania, 200635
Contact: Larisa Sandulescu, MD, PhD    40723968354    larisasandulescu@yahoo.com   
Principal Investigator: Adrian Saftoiu, Md, PhD         
University of Medicine and Pharmacy Recruiting
Timisoara, Timis, Romania, 200635
Contact: Alina Popescu, MD, PhD       alinamirceapopescu@yahoo.com   
Principal Investigator: Ioan Sporea, MD, PhD         
Sponsors and Collaborators
University of Medicine and Pharmacy Craiova
UNIVERSITY OF MEDICINE AND PHARMACY TIMISOARA
Investigators
Principal Investigator: Adrian Saftoiu, MD, PhD UMF Craiova
  More Information

No publications provided

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
Digestive System Diseases

ClinicalTrials.gov processed this record on November 25, 2014