The Role of Strain Elastography in Staging Liver Fibrosis

NCT02184000 | Unknown DMC

• 1 other identifier: Real-Time Elasto
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cirrhosis; Chronic Liver Disease

Keywords

strain elastography; hepatopathy; liver fibrosis

Outcome Measures

Primary Outcomes (1)

• Strain Elastography results

  Usefulness of strain 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 B or C

3. pacients with liver cirrhosis type B or C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• University of Medicine and Pharmacy Craiova: lead
• University of Medicine and Pharmacy "Victor Babes" Timisoara: collaborator

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 (5)

• Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.

  PMID: 18334275 BACKGROUND

• de Ledinghen V, 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. doi: 10.1111/j.1478-3231.2010.02258.x. Epub 2010 May 14.

  PMID: 20492500 BACKGROUND

• Friedrich-Rust M, Nierhoff J, Lupsor M, Sporea I, Fierbinteanu-Braticevici C, Strobel D, Takahashi H, Yoneda M, Suda T, Zeuzem S, Herrmann E. Performance of Acoustic Radiation Force Impulse imaging for the staging of liver fibrosis: a pooled meta-analysis. J Viral Hepat. 2012 Feb;19(2):e212-9. doi: 10.1111/j.1365-2893.2011.01537.x. Epub 2011 Oct 30.

  PMID: 22239521 BACKGROUND

• Koizumi Y, Hirooka M, Kisaka Y, Konishi I, Abe M, Murakami H, Matsuura B, Hiasa Y, Onji M. 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 Feb;258(2):610-7. doi: 10.1148/radiol.10100319.

  PMID: 21273523 BACKGROUND

• Gheonea DI, Saftoiu A, Ciurea T, Gorunescu F, Iordache S, Popescu GL, Belciug S, Gorunescu M, Sandulescu L. Real-time sono-elastography in the diagnosis of diffuse liver diseases. World J Gastroenterol. 2010 Apr 14;16(14):1720-6. doi: 10.3748/wjg.v16.i14.1720.

  PMID: 20380003 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Digestive System Diseases; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases

Study Officials

• Adrian Saftoiu, MD, PhD

  UMF Craiova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larisa SANDULESCU, MD, PhD

CONTACT

+40723968354; larisasandulescu@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: July 2, 2014
• First Posted: July 8, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 8, 2014

Record last verified: 2014-06

Locations

RO (2)