Authors' objectives:

To study the scientific evidence regarding effectiveness and safety of TE in the diagnosis of liver fibrosis as compared to hepatic biopsy, and assess the foreseeable impact of using this test.

Authors' recommendations: 1) Current scientific evidence regarding TE shows that it is a valid technology for diagnosing liver fibrosis due to different aetiologies, especially to confirm the presence of cirrhosis. In patients diagnosed with cirrhosis using FibroScan, the performance of a biopsy could be avoided. However, its use to discern between early and intermediate stages of fibrosis is limited.2) To achieve maximum accuracy in results using FibroScan, the procedure should be carried out following the manufacturer’s indications. Technological improvements are being carried out to try to resolve some of the limitations which have appeared in using this technology, such as new probes to use with obese patients or for individuals with small intercostal spaces.3) The use of FibroScan could avoid using biopsies in a significant number of patients, thus reducing the risk associated which such test.4) TE is a safe test, well accepted by patients, and not associated with complications nor adverse effects.5) The introduction of FibroScan as a diagnostic technology in health services does not imply relevant organizational changes. TE could be carried out, as well as at the hospital level, in specialised consultations as it is an easily carried out procedure and does not need to be performed by medical personnel.6) FibroScan is not an expensive technology. It is foreseeable that its use will lead to a reduction in costs, although cost-effectiveness and cost-utility studies are needed to assess this.7) It would be advisable to study the use of TE with other serum biomarkers to properly assess its diagnostic effectiveness in this combined use.8) Due to its safety and good acceptance by the patient, TE could be a useful tool to study liver fibrosis in children and to screen for high risk patients.9) At the same time, other possible clinical indications for FibroScan should be explored, such as its prognostic capability and its repercussion in therapeutic decision-making. It is foreseeable that FibroScan could be used to select patients which should undergo treatment and indicate the best time to begin such treatment. In addition, TE could become the chosen technique to follow up fibrosis and monitor treatment, assessing fibrosis progression or regression.

Project Status: Completed

URL for project: http://www.isciii.es/htdocs/publicaciones/documentos/59_Fibroscan.pdf

Year Published: 2009

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Luis M. Sánchez Gómez

Contact Email: luism.sanchez@isciii.es

Copyright: Agencia de Evaluacion de Tecnologias Sanitarias (AETS)