Breast Ductal Lavage for Cancer Risk Assessment
DESCRIPTION
Ductal lavage of the mammary ducts is intended as diagnostic and risk assessment tool to evaluate individuals at risk for breast cancer. This procedure involves several steps. First, nipple aspiration is performed to identify fluid-yielding mammary ducts. Then, a flexible microcatheter is inserted into the nipple. A small amount of saline is slowly instilled and then removed with cells from the milk ducts. These cells are examined for cytologic abnormalities.
POLICY
Ductal lavage for the detection of breast cancer and for the detection of breast cancer in the evaluation of women at high risk is considered investigational.
See also:
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Breast ductal lavage may assist in detecting atypical cytology. However, there is no scientific evidence that this knowledge in any way alters the health outcomes expected from conventional treatments readily available now.
SOURCES
American Cancer Society. (2010). Cancer Screening in the United States,2010: A review of current American Cancer Society guidelines and issues in cancer screening. Retrieved September 22, 2010 from http://caonline.amcancersoc.org/cgi/reprint/60/2/99.
American Society of Breast Surgeons. (2007, May). Official statement: Ductal cell-based risk assessment statement. Retrieved September 22, 2010 from http://www.breastsurgeons.org/statements/PDF_Statements/Ductal_Cell.pdf.
Arun, B. (2004). Ductal lavage and risk assessment of breast cancer. Oncologist, 9 (6); 599-605.(Level 5 Evidence)
Arun, B., Valero, V., Logan, C., Broglio, K., Rivera, E., Brewster, A., et al. (2007). Comparison of ductal lavage and random periareolar fine needle aspiration as tissue acquisition methods in early breast cancer prevention trials. Clinical Cancer Research, 15 (13), 4943-4948. (Level 4 Evidence - Independent study)
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2009). Epithelial cell cytology in breast cancer risk assessment and high-risk patient management (ductal lavage and suction collection systems) (2.01.45). Retrieved September 22, 2010 from BlueWeb. (26 articles and/or guidelines reviewed)
Carruthers, C. D., Chapleskie, L. A., Flynn, M. B., & Frazier, T. G. (2007). The use of ductal lavage as a screening tool in women at high risk for developing breast carcinoma. The American Journal of Surgery, 194 (4), 463-466. (Level 2 Evidence - Independent study)
ECRI Institute. Health Technology Information Service. Evidence Reports. (2002, July). Ductal lavage and nipple aspiration for identifying women at high risk of breast cancer. September 22, 2010 from ECRI Institute. (71 articles and/or guidelines reviewed)
Khan, S., Lankes, H., Patil, D., Bryk, M., Hou, N., Ivancic, D., et al. (2009). Ductal lavage is an inefficient method of biomarker measurement in high-risk women. Cancer Prevention Research, 2 (3), 256 - 273. (Level 4 Evidence)
Loud, J., Thiebaut, A., Abati, A., Filie, A., Nichols, K., Danforth, D., et al. (2009). Ductal lavage in women from BRAC ½ families: is there a future for ductal lavage in women at increased genetic risk of breast cancer? Cancer Epidemiology Biomarkers and Prevention, 18 (4), 1243 - 1251. (Level 4 Evidence)
National Cancer Institute. (2010, September). Breast cancer screening (PDQA®): Breast Cancer Screening Modalities. Retrieved September 22, 2010 from http://www.cancer.gov/cancertopics/pdq/screening/breast/HealthProfessional/page4.
National Comprehensive Cancer Network. (2009, November). NCCN clinical practice guidelines in oncology™. Breast cancer screening and diagnosis. (V.1.2010). Retrieved September 22, 2010 from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
National Comprehensive Cancer Network. (2009, November). NCCN clinical practice guidelines in oncology™. Breast cancer risk reduction. (V.1.2010). Retrieved September 22, 2010 from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
U. S. Food and Drug Administration. (1999, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K993342. Retrieved September 22, 2010 from http://www.fda.gov/cdrh/pdf/k993342.pdf.
U. S. Food and Drug Administration. (2000, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K000135. Retrieved September 22, 2010 from http://www.fda.gov/cdrh/pdf/k000135.pdf.
U. S. Food and Drug Administration. (2003, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K030443. Retrieved September 22, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/k030443.pdf.
Visvanathan, K., Santor, D., Ali, S. Z., Brewster, A., Arnold, A., Armstron, D. K., et al. (2007). The reliability of nipple aspirate and ductal lavage in women at increased risk for breast cancer - A potential tool for breast cancer risk assessment and biomarker evaluation. Cancer Epidemiology, Biomarkers & Prevention, 16 (5), 950-955. (Level 2 Evidence - Independent study)
West, K. E., Wojcik, E. M., Dougherty, T. A., Siziopikou, K. P., Albain, K. S., & Gabram, S. (2006). Correlation of nipple aspiration and ductal lavage cytology with histopathologic findings for patients before scheduled breast biopsy examination. The American Journal of Surgery, 191 (1), 57-60. (Level 3 Evidence - Independent study)
Winifred S. Hayes, Inc. Medical Technology Directory. (2004, August). Breast ductal lavage and fiberoptic ductoscopy for breast cancer diagnosis and screening. Retrieved September 22, 2010 from www.Hayesinc.com/subscribers (36 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2004, August; last update search December 2008). Breast ductal lavage and fiberoptic ductoscopy for breast cancer diagnosis and screening. Retrieved September 22, 2010 from www.Hayesinc.com/subscribers. (5 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 7/1/2002
MOST RECENT REVIEW DATE: 12/9/2010
ID_BT
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