Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity - Norms in ARFI: Distribution and Reproducibility of ARFI Values in Disease-free Livers or Pathological Livers.
18 Years
N/A
Both
Liver Fibrosis, Liver Cirrhosis, Viral Hepatitis, Liver Tumour, Cardiac Failure, Biliary Cholestasis.
Trial Information
Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity - Norms in ARFI: Distribution and Reproducibility of ARFI Values in Disease-free Livers or Pathological Livers.
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.
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 required
examination
- 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 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 of
disruption of the elasticity and inability to carry patient.
- Chronic heart insufficiency.
- deprived of their liberty by court
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver.
Outcome Time Frame:
One or two 30 min visit according to the patient group
Safety Issue:
No
Principal Investigator
Nora FRULIO, Md MSc
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Bordeaux
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CHUBX 2009/21
NCT ID:
NCT01082419
Start Date:
April 2010
Completion Date:
April 2012
Related Keywords:
- Liver Fibrosis
- Liver Cirrhosis
- Viral Hepatitis
- Liver Tumour
- Cardiac Failure
- Biliary Cholestasis.
- Liver stiffness measurement
- ARFI
- fibrosis
- hepatopathy
- Cholestasis
- Fibrosis
- Heart Failure
- Hepatitis
- Hepatitis A
- Liver Cirrhosis
- Liver Neoplasms
- Hepatitis C
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