An interventional study of ARFI measurement and ARFI measurement in Liver Fibrosis, Liver Cirrhosis and Viral Hepatitis, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic
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.
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:
patients with reversible liver diseases:
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 109 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
healthy volunteers
Device: ARFI measurement
patients with supposed disease free liver (normal hepatic and pancreatic biochemistry)
Device: ARFI measurement
patients with cirrhosis
Device: ARFI measurement
patients with liver tumour and surgery indication
Device: ARFI measurement
patients with reversible liver diseases and with acute left cardiac insufficiency
Device: ARFI measurement
patients with non cirrhotic hepatopathy
Device: ARFI measurement
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 group A the measurement is made by a second and a third investigator during the same examination.
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.
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.
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
Inter and intra observer reproducibility
Time frame: Three 30 min visits in healthy volunteer group.
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.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Bordeaux