NCT01948687

Brief Summary

AIM To evaluate the role of real time elastography (ARFI and Hitachi elastography) in noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

7 months

First QC Date

September 3, 2013

Last Update Submit

September 18, 2013

Conditions

CirrhosisChronic Liver Disease

Keywords

real time elastographyhepatitis

Outcome Measures

Primary Outcomes (1)

  • Real Time Elastography result

    Value of real time elastography recordings for the evaluation of liver fibrosis.

    up to 24 weeks

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • age over 18 years old
  • Study will include three groups of patients as follows:
  • Group I: patients with chronic hepatitis B or C (defined by the presence of serum anti HCV antibody or serum hepatitis B surface antibody)
  • Group II (the control group): healthy adult volunteers
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Researche Center of Gastroenterology and Hepatology

Craiova, Dolj, 200635, Romania

RECRUITING

University of Medicine and Pharmacy

Timișoara, Timiș County, 200635, Romania

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

FibrosisHepatitis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • Adrian Saftoiu, MD, PhD

    UMF Craiova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Larisa D Sandulescu, MD, PhD

CONTACT

+40723968354larisasandulescu@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, MSc Specialist in Gastroenterology

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 24, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2014

Study Completion

November 1, 2014

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

RO(2)