Breast Duct Endoscopy
DESCRIPTION
Breast cancer is thought to start in the lining of the milk duct or lobule. Techniques are being investigated to provide direct access to breast ducts through the nipple. Breast duct endoscopy is a technique that provides for direct visual examination of the breast ducts through nipple orifice cannulation and exploration. The breast duct endoscopy technique is performed under sedation. The procedure involves the enlargement of the duct at the nipple with small metal wires. A ductoscope, which is a small tube with a camera attached, is passed into the duct and advanced into the breast. Water may be injected through the scope into the duct to allow easier passage of the scope. Fluid may be collected through the scope and examined and/or a very thin wire probe may be passed up to several inches into the breast to sample any abnormalities that might be found. The ductoscopy findings are recorded on videotape.
This is currently being performed in research centers and clinical trials for use in various clinical situations. One example is its use as a diagnostic tool for women with spontaneous nipple discharge where endoscopy might function as an alternative to surgical excision. Another example is its use as a follow-up test for women with atypical cytology detected by ductal lavage. In addition, breast duct endoscopy has been used to define margins of surgical resection for delineation of intraductal disease. A final example is its use in the direct delivery of therapeutic agents such as photodynamic therapy, laser ablation and topical biological agents.
POLICY
Breast duct endoscopy is considered not medically necessary.
See also:
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
Published data suggest that breast duct endoscopy is feasible. However, there is minimal published information about how this procedure would be used in the management of the patient, i.e., either in determining the need for other diagnostic tests, such as mammography, ductography, biopsy, excision, or determining the extent of surgical excision. The current literature does not validate the efficacy and safety or impact on health outcomes of this technology over conventional diagnostic methods.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2008). Breast duct endoscopy (2.01.55). Retrieved September 23, 2011 from BlueWeb. (19 articles and/or guidelines reviewed)
Escobar, P. F., Crowe, J. P., Matsunga, T., & Mokbel, K. (2006). The clinical application of mammary ductoscopy. The American Journal of Surgery, 191 (2), 211-215.
Flanagan, M., Love, S., & Hwang, E. S. (2010). Status of intraductal therapy for ductal carcinoma in situ. Current Breast Cancer Reports, 2 (2), 75-82.
Hahn, M., Fehm, T., Solomayer, E., Siegmann, K., Hengstmann A., Wallwiener, D., et al. (2009). Selective microdochectomy after ductoscopic wire marking in women with pathological nipple discharge. BMC Cancer, 9 (151). (Level 3 Evidence - Independent study)
Hunerbein, M., Dubowy, A., Raubach, M., Gebauer, B., Topalidis, T., & Schlag, P. (2007). Gradient index ductoscopy and intraductal biopsy of intraductal breast lesions. American Journal of Surgery, 194 (4), 511-514. (Level 3 Evidence - Independent study)
National Comprehensive Cancer Network. (2010, November). NCCN clinical practice guidelines in oncology™. Breast cancer screening and diagnosis - V1.2011. Retrieved September 23, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf.
Simpson, J., Connolly, E., Leong, W., Escallon, J., McCready, D., Reedijk, M., et al. (2009). Mammary ductoscopy in the evaluation and treatment of pathologic nipple discharge: A Canadian experience. Canadian Journal of Surgery, 52 (6), E245-E248. (Level 3 Evidence - Independent study)
U. S. Food and Drug Administration. (2000, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K001098. Retrieved September 23, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K001098.pdf.
U. S. Food and Drug Administration. (2001, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K011189. Retrieved September 23, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K011189.pdf.
Zagouri, F., Sergentanis, T. N., Giannakopoulou, G., Panopoulou, E., Chrysikos, D., Bletsa, G., et al. (2009). Breast ductal endoscopy: How many procedures qualify? BMC Research Notes, 2, (115).
ORIGINAL EFFECTIVE DATE: 10/1/2003
MOST RECENT REVIEW DATE: 1/8/2012
ID_BA
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