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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A01088-49 | Other Identifier | ANSM |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | healthy volunteers |
|
| Group B | Other | patients with supposed disease free liver (normal hepatic and pancreatic biochemistry) |
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| Group D | Other | patients with cirrhosis |
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| Group E | Other | patients with liver tumour and surgery indication |
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| Group F | Other | patients with reversible liver diseases and with acute left cardiac insufficiency |
|
| Group C | Other | patients with non cirrhotic hepatopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARFI measurement | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nora FRULIO, Md MSc | University Hospital, Bordeaux | Principal Investigator |
| Adelaïde Doussau, MD, Msc | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bordeaux | Bordeaux | 33075 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19022517 | Background | 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. | |
| 18334275 | Background | 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. |
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| Group G | Other | patients with reversible liver diseases and with biliary cholestasis |
|
| ARFI measurement | Device | 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 measurement | Device | 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. |
|
| 18395077 | Background | 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. |
| 17715090 | Background | 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. |
| 17312065 | Background | 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. |
| 19670411 | Result | Frulio N, Laumonier H, Balabaud C, Trillaud H, Bioulac-Sage P. Hepatic congestion plays a role in liver stiffness. Hepatology. 2009 Nov;50(5):1674-5. doi: 10.1002/hep.23109. No abstract available. |
| 21349784 | Result | Frulio N, Balabaud C, Bioulac-Sage P. Can elastometry be used for a better identification of cirrhosis? Clin Res Hepatol Gastroenterol. 2011 Mar;35(3):166-8. doi: 10.1016/j.clinre.2010.12.012. Epub 2011 Feb 23. |
| 22798311 | Result | Laumonier H, Frulio N, Laurent C, Balabaud C, Zucman-Rossi J, Bioulac-Sage P. Focal nodular hyperplasia with major sinusoidal dilatation: a misleading entity. BMJ Case Rep. 2010 Dec 1;2010:bcr0920103311. doi: 10.1136/bcr.09.2010.3311. |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006528 | Carcinoma, Hepatocellular |
| D006333 | Heart Failure |
| D005355 | Fibrosis |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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