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

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01082419

Acronym

NARFI

Enrollment

109

Registered

2010-03-08

Start date

2010-04-01

Completion date

2013-04-01

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Cholestasis, Cardiac Failure, Liver Cirrhosis, Liver Fibrosis, Liver Tumour, Viral Hepatitis

Keywords

Liver stiffness measurement, ARFI, fibrosis, hepatopathy

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.

Detailed 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.

Interventions

DEVICEARFI measurement

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNora FRULIO, Md MSc

University Hospital, Bordeaux

STUDY_CHAIRAdelaïde Doussau, MD, Msc