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

University Hospital of Bordeaux

Status: Completed

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

Treatments: Device: ARFI measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT01082419

CHUBX 2009/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 7 patient groups

Group A

Other group

Description:

healthy volunteers

Treatment:

Device: ARFI measurement

Device: ARFI measurement

Device: ARFI measurement

Group B

Other group

Description:

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

Treatment:

Device: ARFI measurement

Device: ARFI measurement

Device: ARFI measurement

Group D

Other group

Description:

patients with cirrhosis

Treatment:

Device: ARFI measurement

Device: ARFI measurement

Device: ARFI measurement

Group E

Other group

Description:

patients with liver tumour and surgery indication

Treatment:

Device: ARFI measurement

Device: ARFI measurement

Device: ARFI measurement

Group F

Other group

Description:

patients with reversible liver diseases and with acute left cardiac insufficiency

Treatment:

Device: ARFI measurement

Device: ARFI measurement

Device: ARFI measurement

Group C

Other group

Description:

patients with non cirrhotic hepatopathy

Treatment:

Device: ARFI measurement

Device: ARFI measurement

Device: ARFI measurement

Group G

Other group

Description:

patients with reversible liver diseases and with biliary cholestasis

Treatment:

Device: ARFI measurement

Device: ARFI measurement

Device: ARFI measurement