Medicine Section - Breast Duct Endoscopy (Ductoscopy)

IMPORTANT REMINDER

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PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

Breast duct endoscopy is a technique that provides for direct visual examination of the breast ducts through nipple orifice cannulation and exploration. It may also be referred to as ductoscopy or mammoscopy. 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 for women with atypical cytology as detected by ductal lavage (see Medicine policy No. 93).
  
  
• 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 CT-scans are now being studied in another approach referred to as virtual ductoscopy.

Note: This policy addresses breast duct endoscopy only. For discussions of breast epithelial cell cytology (ductal lavage), see Regence Medical Policy, Medicine, Policy No. 93.

POLICY/CRITERIA

Breast duct endoscopy, also known as ductoscopy, is considered investigational.

SCIENTIFIC BACKGROUND

While published data suggest that breast duct endoscopy is feasible, no randomized, controlled trials have been reported. Ductoscopy has been shown to be feasible in a number of large case series. ^[1-3] Outcomes from recently published nonrandomized studies on diagnostic capability continue to be mixed, with many concluding that further data from larger clinical trials will be required to determine the sensitivity, specificity and positive and negative predictive values of ductoscopy.  Although a number of authors have concluded that ductoscopy is a valuable diagnostic tool, there is a lack of direct comparison between ductoscopy and other diagnostic techniques.  In addition, there is minimal data reporting on how the results of ductoscopy influence either the decision to undergo biopsy or excision, or influence the extent of the excision. ^[1,4-10]

As endoscopic technology advances, therapeutic uses for ductoscopy are being explored, but current data are limited to preliminary feasibility studies and outcomes are mixed.   For example, Vaughan et al reported ductoscopy to be useful for lesion localization and intraoperative guidance, but not helpful in preoperative evaluation. ^[11] In contrast, a literature review by Uchida et al concluded that ductoscopy was useful for diagnosing intraductal lesions in patients with nipple discharge, but ductoscopic biopsy and therapeutic interventions need further development. ^[12]

The following articles are representative of the content and study design quality of current published literature.  Louie conducted a retrospective study of patients with nipple discharge who underwent ductoscopy and had a diagnosis of cancer. ^[13] In this small series of cancer patients, duct wall irregularities or intraluminal growths were noted during ductoscopy in 57% (8 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. ^[14] In this case series, intraductal lesions were noted in 41% of patients with breast cancer. In addition, 16% of “normal” ducts had extensive intraductal lesions. Grunwald and colleagues compared various diagnostic tests in patients with breast disease. ^[15] 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% in this series. Duct sonography showed the highest sensitivity (67.3%), followed by MRI (65.2%), galactography(56.3%), ductoscopy (55.2%), and FNAC (51.9%). The highest specificity was shown by FNAC, core biopsy, and galactography (each 100.0%), followed by mammography (92.3%), nipple smear (77.8%), ductoscopy, and duct sonography (each 61.5%); the lowest specificity was displayed by MRI (25.0%). The authors felt these results were promising. In contrast to these results, in a study from China involving 1048 women evaluated between 1997 and 2005, Liu identified 49 of 52 (94%) of cancers among women presenting with spontaneous nipple discharge. ^[16] However evaluation and follow-up was limited among the 489 cases that had normal ductoscopy and cytology. The authors did 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. In 2010, Tang and colleagues conducted a literature review and reported a continued lack of prospective randomized trials, noting that these “would be crucial to validate current opinion.” ^[17] The authors concluded that the role of breast duct endoscopy in breast cancer screening and conservative surgery has yet to be fully defined. 

Summary

The data are insufficient to permit scientific conclusions regarding the role breast duct endoscopy in the evaluation and management of patients with known or suspected breast cancer. Further studies are needed to better define both the clinical validity and clinical utility of this technique in appropriate populations.

Practice Guidelines and Position Statements

No guidelines or position statements were found that recommend the use of breast ductoscopy for screening, diagnosis, or treatment of breast cancer. The 2011 NCCN guidelines for evaluation of patients with nipple discharge do not recommend breast duct endoscopy. ^[18]

REFERENCES

1. Matsunaga, T, Kawakami, Y, Namba, K, Fujii, M. Intraductal biopsy for diagnosis and treatment of intraductal lesions of the breast. Cancer. 2004 Nov 15;101(10):2164-9.  PMID: 15484220
2. Sauter, ER, Ehya, H, Klein-Szanto, AJ, Wagner-Mann, C, MacGibbon, B. Fiberoptic ductoscopy findings in women with and without spontaneous nipple discharge. Cancer. 2005 Mar 1;103(5):914-21.  PMID: 15666326
3. Sauter, ER, Ehya, H, Schlatter, L, MacGibbon, B. Ductoscopic cytology to detect breast cancer. Cancer J. 2004 Jan-Feb;10(1):33-41; discussion 15-6.  PMID: 15000493
4. Shen, KW, Wu, J, Lu, JS, et al. Fiberoptic ductoscopy for breast cancer patients with nipple discharge. Surg Endosc. 2001 Nov;15(11):1340-5.  PMID: 11727147
5. Shen, KW, Wu, J, Lu, JS, et al. Fiberoptic ductoscopy for patients with nipple discharge. Cancer. 2000 Oct 1;89(7):1512-9.  PMID: 11013365
6. Dooley, WC. Routine operative breast endoscopy during lumpectomy. Ann Surg Oncol. 2003 Jan-Feb;10(1):38-42.  PMID: 12513958
7. Dooley, WC, Francescatti, D, Clark, L, Webber, G. Office-based breast ductoscopy for diagnosis. Am J Surg. 2004 Oct;188(4):415-8.  PMID: 15474438
8. Sauter, ER, Klein-Szanto, A, Macgibbon, B, Ehya, H. Nipple aspirate fluid and ductoscopy to detect breast cancer. Diagn Cytopathol. 2010 Apr;38(4):244-51.  PMID: 19795490
9. 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 Sep-Oct;13(5):418-23.  PMID: 16962525
10. Al Sarakbi, W, Salhab, M, Mokbel, K. Does mammary ductoscopy have a role in clinical practice? Int Semin Surg Oncol. 2006;3:16.  PMID: 16808852
11. Vaughan, A, Crowe, JP, Brainard, J, Dawson, A, Kim, J, Dietz, JR. Mammary ductoscopy and ductal washings for the evaluation of patients with pathologic nipple discharge. Breast J. 2009 May-Jun;15(3):254-60.  PMID: 19645780
12. Uchida, K, Fukushima, H, Toriumi, Y, et al. Mammary ductoscopy: current issues and perspectives. Breast Cancer. 2009;16(2):93-6.  PMID: 19016310
13. 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 Oct;192(4):530-3.  PMID: 16978968
14. Hunerbein, M, Dubowy, A, Raubach, M, Gebauer, B, Topalidis, T, Schlag, P. Gradient index ductoscopy and intraductal biopsy of intraductal breast lesions. Am J Surg. 2007 Oct;194(4):511-4.  PMID: 17826068
15. 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 May;30(5):243-8.  PMID: 17460418
16. 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 Mar;108(2):271-7.  PMID: 17473979
17. Tang, SS, Twelves, DJ, Isacke, CM, Gui, GP. Mammary ductoscopy in the current management of breast disease. Surg Endosc. 2010 Dec 18.  PMID: 21170661
18. Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis, V.1.2011. [cited 01/09/2011]; Available from: http://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf

CROSS REFERENCES

Epithelial Cell Cytology in Breast Cancer Risk Assessment and High Risk Patient Management (Ductal Lavage and Suction Collection Systems), Regence Medical Policy Manual, Medicine, Policy No. 93

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