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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01082419
First received: March 5, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Liver Fibrosis
Liver Cirrhosis
Viral Hepatitis
Liver Tumour
Cardiac Failure
Biliary Cholestasis.
Device: ARFI measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver. [ Time Frame: One or two 30 min visit according to the patient group ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inter and intra observer reproducibility [ Time Frame: Three 30 min visits in healthy volunteer group. ] [ Designated as safety issue: No ]
  • Median (m/s) of ARFI values between before and after effective treatment for liver reversible disease [ Time Frame: From patient admission until patient healing in groups F&G. ] [ Designated as safety issue: No ]

Estimated Enrollment: 205
Study Start Date: April 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
healthy volunteers
Device: ARFI 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.

Group B
patients with supposed disease free liver (normal hepatic and pancreatic biochemistry)
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Group D
patients with cirrhosis
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Group E
patients with liver tumour and surgery indication
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Group F
patients with reversible liver diseases and with acute left cardiac insufficiency
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.

Group C
patients with non cirrhotic hepatopathy
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Group G
patients with reversible liver diseases and with biliary cholestasis
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082419

Contacts
Contact: Nora FRULIO, Md MSc +33 (0) 5 56 79 58 00 nora.frulio@chu-bordeaux.fr

Locations
France
University Hospital Bordeaux Recruiting
Bordeaux, France, 33075
Contact: Nora FRULIO, Md MSc    +33 (0) 5 56 79 58 00    nora.frulio@chu-bordeaux.fr   
Sub-Investigator: Herve Trillaud         
Sub-Investigator: Herve LAUMONIER         
Sub-Investigator: Thibault Carteret, Dr         
Sub-Investigator: Hugues Castagnede, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Nora FRULIO, Md MSc University Hospital, Bordeaux
Study Chair: Adelaïde Doussau, MD, Msc Bordeaux University Hospital
  More Information

Publications:
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01082419     History of Changes
Other Study ID Numbers: CHUBX 2009/21
Study First Received: March 5, 2010
Last Updated: April 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Liver stiffness measurement
ARFI
fibrosis
hepatopathy

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Cholestasis
Heart Failure
Pathologic Processes
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014