Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity

NCT01082419 | Completed

• 1 other identifier: CHUBX 2009/21
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate liver fibrosis in patients with chronic liver diseases. However, there is growing evidence that fibrosis is not the only determinant of liver stiffness. Indeed inflammation, cholestasis, congestion could also interfere with stiffness measurements. Acoustic radiation force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard ultrasonographic probe, it offers elastography with a flexible metering box at variable depth, allowing the examination of specific area.

Conditions

Liver Fibrosis; Liver Cirrhosis; Viral Hepatitis; Liver Tumour; Cardiac Failure; Biliary Cholestasis.

Keywords

Liver stiffness measurement; ARFI; fibrosis; hepatopathy

Outcome Measures

Primary Outcomes (1)

• The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver.

  One or two 30 min visit according to the patient group

Secondary Outcomes (2)

• Inter and intra observer reproducibility

  Three 30 min visits in healthy volunteer group.

• Median (m/s) of ARFI values between before and after effective treatment for liver reversible disease

  From patient admission until patient healing in groups F&G.

Study Arms (7)

Group A

OTHER

healthy volunteers

Device: ARFI measurement

Group B

OTHER

patients with supposed disease free liver (normal hepatic and pancreatic biochemistry)

Device: ARFI measurement

Group D

OTHER

patients with cirrhosis

Device: ARFI measurement

Group E

OTHER

patients with liver tumour and surgery indication

Device: ARFI measurement

Group F

OTHER

patients with reversible liver diseases and with acute left cardiac insufficiency

Device: ARFI measurement

Group C

OTHER

patients with non cirrhotic hepatopathy

Device: ARFI measurement

Group G

OTHER

patients with reversible liver diseases and with biliary cholestasis

Device: ARFI measurement

Interventions

ARFI measurement DEVICE

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea. For group A the measurement is made by a second and a third investigator during the same examination.

Group A

Eligibility Criteria

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

You may qualify if:

• Man or Woman
• Age\> 18 years old
• Able to understand the study and to give informed consent
• Informed consent signed by patient and investigator before any study required examination
• With a valid health insurance
• Group A : healthy volunteers without known liver disease
• Group B : voluntary patients without known liver disease
• Group C and D Patient with a diagnosed chronic liver disease
• Group E : patients with liver tumors (benign or malignant) with surgical indication
• Group F : patients with acute right heart insufficiency diagnosed by a cardiologist
• Group G :patients with biliary cholestasis and imaging evidence of biliary dilatation

You may not qualify if:

• Patient under 18 years old
• Not able to understand the study or to give their consent.
• Pregnant woman
• Severe respiratory insufficiency
• Unable to perform a "light" apnea .
• hemodynamic instability (cardiogenic shock, septic or anaphylactic) possibility of disruption of the elasticity and inability to carry patient.
• Chronic heart insufficiency.
• deprived of their liberty by court

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital Bordeaux

Bordeaux, 33075, France

Location

Related Publications (5)

• Bonekamp S, Kamel I, Solga S, Clark J. Can imaging modalities diagnose and stage hepatic fibrosis and cirrhosis accurately? J Hepatol. 2009 Jan;50(1):17-35. doi: 10.1016/j.jhep.2008.10.016. Epub 2008 Nov 8.

  PMID: 19022517 BACKGROUND

• 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

• Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18.

  PMID: 18395077 BACKGROUND

• Ferraioli G, Gulizia R, Filice C. Real-time elastography in the assessment of liver fibrosis. AJR Am J Roentgenol. 2007 Sep;189(3):W170. doi: 10.2214/AJR.07.2318. No abstract available.

  PMID: 17715090 BACKGROUND

• Friedrich-Rust M, Ong MF, Herrmann E, Dries V, Samaras P, Zeuzem S, Sarrazin C. Real-time elastography for noninvasive assessment of liver fibrosis in chronic viral hepatitis. AJR Am J Roentgenol. 2007 Mar;188(3):758-64. doi: 10.2214/AJR.06.0322.

  PMID: 17312065 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Heart Failure; Fibrosis; Digestive System Diseases

Condition Hierarchy (Ancestors)

Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Heart Diseases; Cardiovascular Diseases

Study Officials

• Nora FRULIO, Md MSc

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Adelaïde Doussau, MD, Msc

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

FR (1)