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

Last updated: November 6, 2014
Sponsor: University Hospital, Bordeaux
Overall Status: Completed

Phase

N/A

Condition

Hepatitis

Digestive System Neoplasms

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01082419
CHUBX 2009/21
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 requiredexamination

  • With a valid health insurance

  • Groups specific inclusion criteria are:

  • 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

Exclusion

Exclusion Criteria:

  • 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 ofdisruption of the elasticity and inability to carry patient.

  • Chronic heart insufficiency.

  • deprived of their liberty by court

Study Design

Total Participants: 109
Study Start date:
April 01, 2010
Estimated Completion Date:
April 30, 2013

Study Description

There are many causes of chronic liver diseases such as hepatitis C infection, hepatitis B infection, alcohol, NAFLD (non-alcoholic fatty liver disease), drugs and auto-immune liver disease.

Although the causes differ the pathological response to injury tends to be similar leading to fibrosis and cirrhosis.

Liver biopsy is the current gold standard for the assessment of liver fibrosis but is poorly suited for active monitoring because of its expense and morbidity. Thus, development of alternatives that are safe, inexpensive, and reliable is a priority.

Liver stiffness measurement (LSM) by non invasive method is increasingly used to estimate liver fibrosis in patient with chronic liver disease. 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.

The purpose of this work was to evaluate by ARFI, the efficiency of this new technique, the reproducibility inter and intra observer, and the liver elasticity obtained by this method in different patient groups.

The primary endpoint of this work is to evaluate by ARFI, the efficiency of the technique, the reproducibility inter and intra observer, and the elasticity of liver in 6 different patient groups and healthy volunteers.

The different population groups are:

  • healthy volunteers Group A

  • patients with supposed disease free liver (normal hepatic and pancreatic biochemistry). Group B

  • patients with non cirrhotic hepatopathy. Group C

  • patients with cirrhosis. Group D

  • patients with liver tumour and surgery indication. Group E

  • patients with reversible liver diseases:

    • patients with acute left cardiac insufficiency. Group F

    • patients with biliary cholestasis. Group G

ARFI measurements will be performed in a single liver ultrasound exam visit except for patients with reversible liver diseases who will have a second visit with ARFI measurement after clinical healing. The ARFI values are expressed as a speed in m/s.

Connect with a study center

  • University Hospital Bordeaux

    Bordeaux, 33075
    France

    Site Not Available

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