ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of Strain Elastography in Staging Liver Fibrosis (SELF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
University of Medicine and Pharmacy "Victor Babes" Timisoara
Information provided by (Responsible Party):
Dan Gheonea, University of Medicine and Pharmacy Craiova

Brief Summary:
AIM: To evaluate the role of Strain Elastography in the assessment of liver fibrosis in chronic hepatopathy

Condition or disease
Cirrhosis Chronic Liver Disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Usefulness of the Strain Elastography in the Assessment of Liver Fibrosis in Chronic Hepatopathy
Study Start Date : March 2014
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Group/Cohort
1. the control group healthy adult volunteers
2. patients with chronic hepatitis B or C
3. pacients with liver cirrhosis type B or C



Primary Outcome Measures :
  1. Strain Elastography results [ Time Frame: up to 24 weeks ]
    Usefulness of strain elastography recordings for the evaluation of liver fibrosis



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184000


Contacts
Contact: Larisa 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    arisasandulescu@yahoo.com   
Principal Investigator: Adrian Saftoiu, Saftoiu         
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 "Victor Babes" Timisoara
Investigators
Principal Investigator: Adrian Saftoiu, MD, PhD UMF Craiova

Publications:
Responsible Party: Dan Gheonea, MD, PhD, MSc Specialist in Gastroenterology, University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier: NCT02184000     History of Changes
Other Study ID Numbers: Real-Time Elasto
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: June 2014

Keywords provided by Dan Gheonea, University of Medicine and Pharmacy Craiova:
strain elastography
hepatopathy
liver fibrosis

Additional relevant MeSH terms:
Fibrosis
Liver Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases