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QUANTIFICATION OF LIVER FIBROSIS USING ULTRASOUND TRANSIENT ELASTOGRAPHY (rapid assessment procedure)
When the CEDIT is requested for a new technology, a rapid assessment procedure is performed based on a limited review of the literature. Depending on the results of this assessment, the CEDIT may decide to carry out a complete assessment. The opinion below is the outcome of the initial rapid assessment procedure.
Professor Poupon (Federation of Hepato-Gastro-Enterology, Saint-Antoine hospital Paris) applied to CEDIT for an opinion on the medical value and timeliness of disseminating the Fibroscan® system at AP-HP.
Because all the data in the scientific literature applies only to chronic hepatitis C patient populations, this assessment is applicable to this indication alone.
The Fibroscan® system is currently the only medical device for diagnosing and quantifying liver fibrosis based on the principle of transient elastography. The device produces a mechanical wave by means of vibration. The measurement of the speed of propagation of this wave through the liver parenchyma provides an estimate of the latter's elasticity which is used to estimate the stade of fibrosis.
This is a non-invasive test lasting only 5 to 10 minutes which can be performed by previously trained medical or paramedical staff, yielding an immediate result.
This technology is therefore an alternative to liver needle biopsy , i.e. the reference method for estimating fibrosis in patients suffering from chronic hepatitis C. This technology is easy to use and non-invasive.
Four clinical research articles that assess this technology were found in the literature. From these articles, it appears that the diagnostic value of Fibroscan is equivalent to that of other alternative diagnostic tests to liver biopsy, e.g., biochemical tests. However, no statistically validated comparative study for these tests and no entirely independent study in respect of the company that markets Fibroscan® are available. Therefore, no final conclusion can be reached concerning the true performance of this technology or its status within an overall diagnostic strategy (in addition to the abovementioned biological diagnostic tests).
In economic terms, the investment cost for a Fibroscan comes to €71,760 together with an additional annual maintenance and insurance cost of €5,400. Expenditure on consumable items (ultrasound gel) is negligible. As a result, the cost of using a Fibroscan is highly dependent on the number of examinations performed yearly: at a rate of 20 examinations per year, the unit cost per exam is comparable to that of a liver biopsy (approximately €1,000 per procedure), and at a rate of 150 examinations for year, the cost is approximately €100 per procedure.
In conclusion, the CEDIT recognises the promising potential of this technology, but the absence of conclusive evidence concerning its diagnostic value argues against its immediate dissemination within AP-HP. Additional surveys and comparative studies with other diagnostic tests are needed to provide stringent evidence of this technological innovation's effectiveness. The CEDIT has also noted that there is a lack of consensus concerning the diagnostic approach to liver fibrosis. The combination of a sensitive test with a specific one could be offered under the screening strategy. The CEDIT wishes to review this file in one year's time to determine the status of the various alternative diagnostic methods to liver biopsy within that strategy.
Assessment issued at the plenary session of 14th December, 2004.
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