Description:
Breast duct endoscopy is a technique that provides for direct visual examination of the breast ducts through nipple orifice cannulation and exploration. The technique has been investigated in the following clinical situations:

• Diagnostic technique in women with spontaneous nipple discharge, where endoscopy might function as an alternative to surgical excision
• Technique to obtain cellular material to stratify women for risk of breast cancer
• As a follow-up test for women with atypical cytology as detected by ductal lavage (See policy No. 20145)
• Delineation of intraductal disease to define margins of surgical resection
• The direct delivery of therapeutic agents, including photodynamic therapy, laser ablation, topical biological agents, etc.

Of related interest, three-dimensional reconstruction techniques of computed tomography scans are now being studied in another approach referred to as virtual ductoscopy.

Policy:
Breast duct endoscopy (fiberopic ductoscopy) is considered INVESTIGATIONAL.

Ductal lavage as a diagnostic or risk assessment tool for those considered at high risk for breast cancer is considered INVESTIGATIONAL. 

Benefit Application
BlueCard^®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved for marketing by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale:
While published data suggest that breast duct endoscopy is feasible, 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 or ductography, determining the need for biopsy or excision or determining the extent of surgical excision). Love and Barsky published a feasibility study in 1996, in which nine patients scheduled to undergo mastectomy first underwent breast duct endoscopy.¹ The authors concluded that the intraductal approach is feasible for the study of the early changes of breast cancer. Shen and colleagues studied the role of breast duct endoscopy in 259 women with nipple discharge.² In 36 percent of patients, ductoscopy successfully identified an intraductal papillary lesion. Although the authors conclude that ductoscopy is a safe alternative to ductography in guiding subsequent breast surgery, there was no direct comparison between these techniques. The same group of authors subsequently published a larger case series of 415 women with nipple discharge; presumably, this study overlaps with the previous study.³ An intraductal lesion was detected in 40 percent of these 166 patients; 11 were shown to have ductal carcinoma in situ (DCIS). While the authors concluded that ductoscopy may be a useful technique for diagnosing DCIS prior to surgery, there are no data reporting on how the results of ductoscopy influence either the decision to undergo biopsy or excision or the extent of the excision. Dooley reported on a case series of 201 patients who underwent breast endoscopy during a lumpectomy procedure.⁴ The author concluded that ductoscopy could locate additional intraductal lesions outside the lumpectomy site, thus decreasing the incidence of a positive margin of resection. In a subsequent study, Dooley reported on a case series of 88 patients who underwent ductoscopy for nipple discharge or as a follow-up to a ductal lavage (see policy No. 20145); many of the patients also had mammograpic abnormalities. The authors concluded that office ductoscopy with biopsy is both feasible and does identify suspicious or malignant atypia in patients with expressed or spontaneous nipple fluid.⁵ Sauter et al. and Matsunaga and colleagues have also documented the technical feasibility of ductoscopy in large case series of patients with nipple discharge.^6,7

In summary, the available published data consist of uncontrolled case series. The data are insufficient to permit scientific conclusion regarding the role of breast duct endoscopy in the evaluation and management of patients with known or suspected breast cancer.

Louie conducted a retrospective study of patients with nipple discharge who underwent ductoscopy and had a diagnosis of cancer.¹⁴ In this small series of cancer patients, duct wall irregularities or intraluminal growths were noted during ductoscopy in 57 percent (eight of 14) of breast cancer patients. The authors concluded that no clear morphologic changes noted during ductoscopy definitively indicated malignancy. In a study from Europe, Hunerbein reported results using a new, rigid ductoscope during the evaluation of 66 patients with breast cancer and 45 patients with nipple discharge.¹⁵ This new instrument is said to have improved optics as well as an approach for vacuum-assisted biopsy. In this case series, intraductal lesions were noted in 41 percent of patients with breast cancer. In addition, 16 percent of "normal" ducts had extensive intraductal lesions. Grunwald and colleagues compared various diagnostic tests in patients with breast disease.¹⁶ In this study, ductoscopy was compared to mammography, galactography, sonography, magnetic resonance imaging (MRI), nipple smear, fine-needle aspiration cytology (FNAC) and high-speed core biopsy. However, not all patients received all evaluations; for example, only 19 patients had galactography. There were 71 ductoscopies that were followed up by open biopsies. Here, three invasive and eight ductal carcinomas in situ were found, as well as three atypical ductal hyperplasias, 44 papillomas/papillomatoses (all considered to be disease); and 13 benign findings. Feasibility of ductoscopy was 100 percent in this series. Duct sonography showed the highest sensitivity (67.3 percent), followed by MRI (65.2 percent), galactography (56.3 percent), ductoscopy (55.2 percent) and FNAC (51.9 percent). The highest specificity was shown by FNAC, core biopsy and galactography (each 100.0 percent), followed by mammography (92.3 percent), nipple smear (77.8 percent), ductoscopy and duct sonography (each 61.5 percent); the lowest specificity was displayed by MRI (25.0 percent). The authors believe that these results are promising and indicate that a multicenter European study is underway to further evaluate ductoscopy. Results are expected near the end of 2008. In contrast to these results, in a study from China involving 1,048 women evaluated between 1997 and 2005, Liu identified 49 of 52 (94 percent) cancers among women presenting with spontaneous nipple discharge.¹⁷ However, evaluation and follow-up was limited among the 489 cases that had normal ductoscopy and cytology. The authors do note that 77 of these cases underwent tissue diagnosis within a median follow-up time of 19 months during which one malignancy (DCIS) was diagnosed. The 2008 NCCN guidelines for evaluation of those with nipple discharge again do not recommend breast duct endoscopy.¹⁸ In another paper from a European center, Jacobs describes ongoing research and development in an attempt to have breast ductoscopy become a potential therapeutic as well as a diagnostic approach.¹⁹ The authors comment that these instruments, which require an additional working channel, are not presently available in the United States. Results for use of this technology are viewed as preliminary. Further studies are needed to better define both the clinical validity and clinical utility of this technique in appropriate populations. The policy statement is unchanged; this procedure is considered investigational because its impact on health outcomes is uncertain.

References:

1. Love SM, Barsky SH. Breast-duct endoscopy to study stages of cancerous breast disease. Lancet 1996; 348(9033):997-9.
2. Shen KW, Wu J, Lu JS et al. Fiberoptic ductoscopy for patients with nipple discharge. Cancer 2000; 89(7):1512-9.
3. Shen KW, Wu J, Lu JS et al. Fiberoptic ductoscopy for breast cancer patients with nipple discharge. Surg Endosc 2001; 15(11):1340-5.
4. Dooley WC. Routine operative breast endoscopy during lumpectomy. Ann Surg Oncol 2003; 10(1):38-42.
5. Dooley WC, Francescatti D, Clark L et al. Office-based breast ductoscopy for diagnosis. Am J Surg 2004; 188(4):415-8.
6. Matsunaga T, Kawakami Y, Namba K et al. Intraductal biopsy for diagnosis and treatment of intraductal lesions of the breast. Cancer 2004; 101(10):2164-9.
7. Sauter ER, Ehya H, Schlatter L et al. Ductoscopic cytology to detect breast cancer. Cancer J 2004; 10(1):33-41.
8. Moncrief RM, Nayar R, Diaz LK et al. A comparison of ductoscopy-guided and conventional surgical excision in women with spontaneous nipple discharge. Ann Surg 2005; 241(4):575-81.
9. Sauter ER, Ehya H, Klein-Szanto AJ et al. Fiberoptic ductoscopy findings in women with and without spontaneous nipple discharge. Cancer 2005; 103(5):914-21.
10. Grunwald S, Bojahr B, Schwesinger G et al. Mammary ductoscopy for the evaluation of nipple discharge and comparison with standard diagnostic techniques. J Minim Invasive Gynecol 2006; 13(5):418-23.
11. Al Sarakbi W, Salhab M, Mokbel K. Does mammary ductoscopy have a role in clinical practice? Int Semin Surg Oncol 2006; 3:16.
12. Sharma R, Dietz J, Wright H et al. Comparative analysis of minimally invasive microductectomy versus major duct excision in patients with pathologic nipple discharge. Surgery 2005; 138(4):591-7.
13. NCCN Clinical Practice Guidelines in Oncology. Breast cancer screening and diagnosis guidelines. V.I.2006.
14. Louie LD, Crowe JP, Dawson AE et al. Identification of breast cancer in patients with pathologic nipple discharge: does ductoscopy predict malignancy? Am J Surg 2006; 192(4):530-3.
15. Hunerbein M, Dubowy A, Raubach M et al. Gradient index ductoscopy and intraductal biopsy of intraductal breast lesions. Am J Surg 2007; 194(4):511-4.
16. Grunwald S, Heyer H, Paepke S et al. Diagnostic value of ductoscopy in the diagnosis of nipple discharge and intraductal proliferations in comparison to standard methods. Onkologie 2007; 30(5):243-8.
17. Liu GY, Lu JS, Shen KW et al. Fiberoptic ductoscopy combined with cytology testing in the patients of spontaneous nipple discharge. Breast Cancer Res Treat 2008; 108(2):271-7.
18. NCCN Clinical Practice Guidelines in Oncology. Breast cancer screening and diagnosis guidelines. V.1.2008.
19. Jacobs VR, Paepke S, Ohlinger R et al. Breast ductoscopy: technical development from a diagnostic to an interventional procedure and its future perspective. Onkologie 2007; 30(11):545-9. 

Coding Section

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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