Original Title: Nuevas técnicas percutáneas de diagnóstico histológico de lesiones no palpables sospechosas de cáncer de mama

Authors' objectives: The aim of this research project was to assess the effectiveness, safety and costs of the two new diagnostic techniques of percutaneous puncture guided with digital stereotaxia in non palpable breast lesions: Stereotactic Percutaneous Biopsy (ABBI - SiteSelect) and Vacuum Assisted Biopsy (Mammotome - Vacuflash).

Authors' results and conclusions: Two systematic reviews and 27 original studies of the efficiency and safety of the Vacuum Assisted Biopsy have been detected. If the effectiveness is measured as a proportion of false negatives ranged between 0% and 3.3%. The underestimation of infiltration varied between 0% and 15.74%. This difference also exists when comparing different types of calibres used in the Vacuum Assisted Biopsy. In the case of an 11G Needle, an underestimation occurs in 10.5% of cases, while when an 8G needle is used, this drops to 4.3%. With regard to the most frequent complications involved in this technique, there is the vagal reaction, followed by pain and bruising. With regard to Stereotactic Percutaneous Biopsy, 4 systematic reviews and 25 original articles have been selected. The underestimation of infiltration in this technique stands at between 2.2% and 8.3%. The proportion of false negatives estimated is 3%, although there are no studies with a monitoring period of sufficient length to estimate this parameter correctly. A perusal of the selected studies indicates that in the case of malignant lesions, on 72.61% of occasions there were cancerous cells on the edges of the lesion. The most frequent complication is the haematoma, representing an average of 7.70%. The total cost of tests made with the Vacuum Assisted Biopsy technique (Mamotomo®) during the year 2004, has been estimated at 506€, at 592€ in the case of the Stereotactic Percutaneous Biopsy (Siteselect®) and at 1184€ in the case of the surgical biopsy. DISCUSSION The Vacuum Assisted Biopsy represents a significant improvement on the results of the 14G needle biopsy by obtaining a larger volume and more representative sample, especially in non palpable lesions which are seen as microcalcifications. The Stereotactic Percutaneous Biopsy is a percutaneous technique that allows the complete removal of non palpable lesions. This technique may be appropriate in individualised clinical cases, when it is required to remove a small category BI-RADS 4 or 5 lesion and it is wished to remove this completely with precision and by means of an ambulatory procedure. In general, it is not considered to be a valid procedure for the removal of malignant lesions. Performing a biopsy with the Mamotomo® would represent a saving of 57.26% compared to surgical biopsy. Likewise, a biopsy performed with the Site-Select® represents a cost 50% lower than that of a surgical biopsy. In this country, neither the Vacuum Assisted Biopsy nor the Stereotactic Percutaneous Biopsy are widely used. Nevertheless, the centres where these techniques are used only perform between 4% and 7.12% of surgical biopsies. Likewise, in hospitals where these are used, in comparison with those that do not have these available, a drop in the performance of surgical biopsy from 43.12% to 5.56% is observed.

Authors' recommendations: The need to perform biopsies on a percentage of benign lesions in order to be able to detect malignant lesions at their earliest stages, makes it necessary to provide patients with all the procedures that allow a diagnosis to be performed without the need for surgery. The authors of this report conclude that today, the Vacuum Assisted Biopsy is a good alternative to diagnostic surgical biopsy, with a similar and less aggressive diagnostic effectiveness, taking into account that 70% of these lesions are benign. The Stereotactic Percutaneous Biopsy is a method to remove non palpable lesions in an ambulatory manner and with greater precision than with conventional surgical biopsy, which may be appropriate in selected cases in which it is wished to remove a non fragmented lesion.

Authors' methods: A systematic review has been made of the scientific evidence relating to the aforementioned techniques, as well as an economic analysis and survey in order to determine the degree to which these techniques are implemented in Spain.

Project Status: Completed

Year Published: 2005

URL for published report: http://www9.euskadi.net/sanidad/osteba/datos/d_05-02_lesiones_no_palpables_cancer_mama.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Basque Office for Health Technology Assessment, Health Department Basque Government (OSTEBA)</p>