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

Primary Purpose

Liver Fibrosis, Liver Cirrhosis, Viral Hepatitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ARFI measurement
ARFI measurement
ARFI measurement
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Fibrosis focused on measuring Liver stiffness measurement, ARFI, fibrosis, hepatopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University Hospital Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Other

Other

Other

Other

Other

Other

Other

Arm Label

Group A

Group B

Group D

Group E

Group F

Group C

Group G

Arm Description

healthy volunteers

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

patients with cirrhosis

patients with liver tumour and surgery indication

patients with reversible liver diseases and with acute left cardiac insufficiency

patients with non cirrhotic hepatopathy

patients with reversible liver diseases and with biliary cholestasis

Outcomes

Primary Outcome Measures

The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver.

Secondary Outcome Measures

Inter and intra observer reproducibility
Median (m/s) of ARFI values between before and after effective treatment for liver reversible disease

Full Information

First Posted
March 5, 2010
Last Updated
November 6, 2014
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01082419
Brief Title
Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity
Acronym
NARFI
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, Liver Cirrhosis, Viral Hepatitis, Liver Tumour, Cardiac Failure, Biliary Cholestasis.
Keywords
Liver stiffness measurement, ARFI, fibrosis, hepatopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
healthy volunteers
Arm Title
Group B
Arm Type
Other
Arm Description
patients with supposed disease free liver (normal hepatic and pancreatic biochemistry)
Arm Title
Group D
Arm Type
Other
Arm Description
patients with cirrhosis
Arm Title
Group E
Arm Type
Other
Arm Description
patients with liver tumour and surgery indication
Arm Title
Group F
Arm Type
Other
Arm Description
patients with reversible liver diseases and with acute left cardiac insufficiency
Arm Title
Group C
Arm Type
Other
Arm Description
patients with non cirrhotic hepatopathy
Arm Title
Group G
Arm Type
Other
Arm Description
patients with reversible liver diseases and with biliary cholestasis
Intervention Type
Device
Intervention Name(s)
ARFI measurement
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ARFI measurement
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ARFI measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Inter and intra observer reproducibility
Time Frame
Three 30 min visits in healthy volunteer group.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora FRULIO, Md MSc
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adelaïde Doussau, MD, Msc
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19022517
Citation
Bonekamp S, Kamel I, Solga S, Clark J. Can imaging modalities diagnose and stage hepatic fibrosis and cirrhosis accurately? J Hepatol. 2009 Jan;50(1):17-35. doi: 10.1016/j.jhep.2008.10.016. Epub 2008 Nov 8.
Results Reference
background
PubMed Identifier
18334275
Citation
Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.
Results Reference
background
PubMed Identifier
18395077
Citation
Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18.
Results Reference
background
PubMed Identifier
17715090
Citation
Ferraioli G, Gulizia R, Filice C. Real-time elastography in the assessment of liver fibrosis. AJR Am J Roentgenol. 2007 Sep;189(3):W170. doi: 10.2214/AJR.07.2318. No abstract available.
Results Reference
background
PubMed Identifier
17312065
Citation
Friedrich-Rust M, Ong MF, Herrmann E, Dries V, Samaras P, Zeuzem S, Sarrazin C. Real-time elastography for noninvasive assessment of liver fibrosis in chronic viral hepatitis. AJR Am J Roentgenol. 2007 Mar;188(3):758-64. doi: 10.2214/AJR.06.0322.
Results Reference
background

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

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