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 is considered investigational.
Ductal lavage for the detection of breast cancer in the evaluation of women at high risk is considered investigational.
See also:
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. (2008). Prevention and Early Detection. American Cancer Society guidelines for the early detection of cancer. Retrieved February 10, 2009 from http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/256.cdr#Section_256.
American Society of Breast Surgeons. (2003, April). Official statement: Ductal lavage and cell-based risk assessment. Retrieved February 10, 2009 from http://www.breastsurgeons.org/officialstmts/officialstmt4.shtml.
Arun, B. (2004). Ductal lavage and risk assessment of breast cancer. Oncologist, 9 (6); 599-605.
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. (6:2008). Epithelial cell cytology in breast cancer risk assessment and high-risk patient management (ductal lavage and suction collection systems) (2.01.45). Retrieved February 10, 2009 from BlueWeb. (22 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. Retrieved February 10, 2009 from ECRI Institute. (71 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2004, August). Breast ductal lavage and fiberoptic ductoscopy for breast cancer diagnosis and screening. Retrieved February 10, 2009 from www.Hayesinc.com/subscribers. (36 articles and/or guidelines reviewed)
Khan, S. A., Wiley, E. L., Rodriquez, N., Baird, C., Ramakrishnan, R., Nayar, R., et al. (2004). Ductal lavage findings in women with known breast cancer undergoing mastectomy. Journal of the National Cancer Institute, 96 (20), 1510-1517. (Level 4 Evidence - Independent study)
National Cancer Institute. (2008, August). Breast cancer screening (PDQ®): Breast cancer diagnosis. Retrieved February 10, 2009 from http://www.cancer.gov/cancertopics/pdq/screening/breast/HealthProfessional/page4.
National Cancer Institute. (2008, August). Breast cancer screening (PDQ®): Breast cancer screening modalities. Retrieved February 10, 2009 from http://www.cancer.org/docroot/ped/content/ped_2_3x_acs_cancer_detection_guidelines_36.asp.
Ozanne, E. M., & Esserman, L. J. (2004). Evaluation of breast cancer risk assessment techniques: A cost-effectiveness analysis. Cancer Epidemiology, Biomarkers, & Prevention, 13 (12), 2043-2052. (Level 1 Evidence - Independent study)
U. S. Food and Drug Administration. (1999, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K993342. Retrieved February 10, 2009 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 February 10, 2009 from http://www.fda.gov/cdrh/pdf/k000135.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)
ORIGINAL EFFECTIVE DATE: 7/1/2002
MOST RECENT REVIEW DATE: 3/12/2009
ID_BT
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