Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge

Nipple discharge is the third most common breast related symptom for which women seek medical care, accounting for 37% of all breast complaints. Pathologic nipple discharge (PND) is defined as spontaneous or easily expressible single duct nipple discharge, which contributes to 5% of referrals to breast surgeons. Patients with PND represent a diagnostic and therapeutic challenge for the surgical clinician. The most frequent causes of PND in these cases are intraductal papilloma (IP) in 36% to 66%, ductal carcinoma in situ (DCIS) in 3% to 20% and other benign causes in up to 23%. The evaluation of women with PND usually involves radiological(mammography, ultrasound, ducto (galacto)graphy and cytological (nipple smear, ductal lavage) examinations; however, each of these procedures has found to have low sensitivity and specificity. A ductoscope is an instrument which allows visualization of abnormalities and polypoid lesions within the ductal system with access via the nipple orifice to aid in evaluation of PND. Moreover, it is currently being used to improve localization of lesions in patients with PND. Ductoscopically guided excision is an improvement over standard surgical approaches with terminal duct excision which removes a large volume of tissue with potential cosmetic deformity and for young women may make breast feeding not possible. Ductoscopy also allows retrieval of intraductal cells for diagnostic purposes using brush cytology.

• Ductoscopic papillectomy (Device): Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy

Primary outcomes

• Number of Complete Ductoscopic Retrievals [6 months]: Technical success will be determined by complete (total ductoscopic retrieval of a papilloma) ductoscopic retrieval of lesions over 90% of enrolled patients diagnosed with solitary papilloma.

Secondary outcomes

• Number of Patients With Cessation of Nipple Discharge [Up to 2 weeks from the procedure]: Therapeutic success will be determined by cessation after ductoscopic papillectomy (DP) in over 95% of enrolled patients with pathologic nipple discharge (PND) with a single papilloma.
• Number of Patients With Clinical Recurrence of Nipple Discharge [Up to 2 years]: Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years.

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Be female
* Have pathologic (unilateral/uniductal) nipple discharge
* Been diagnosed with single papilloma
* Be over 18 years of age
* Sign the informed consent form

Exclusion Criteria:

* Have bilateral nipple discharge
* Personal history of breast cancer, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
* Have BRCA 1 or 2 mutation
* Be currently pregnant or pregnant within the last 12 months
* Be currently lactating or lactated within the last 12 months
* Have received chemotherapy in the last 12 months
* Have had a Breast Imaging-Reporting and Data System (BIRADS) 3, 4, 5 or 6 mammograms within the last year
* Have diagnosed with multiple or sessile papilloma by ultrasound, mammography and/or ductoscopy.
* Have suspicious of malignancy in ultrasound
* Have an abnormal finding on the pre-operative nipple smear
* Have Gail Score >1.67
* Have had any subareolar or other surgery
* Have active infections or inflammation in a breast to be studied
* Have a known allergy to lidocaine
* Have abnormal liver function test
* Have medications know to be associated with breast discharge.
* Be unable to attend postoperative visits and imaging work-up.

Participant flow

Outcome results

• Number of Complete Ductoscopic Retrievals (Primary)
• Number of Patients With Cessation of Nipple Discharge (Secondary)
• Number of Patients With Clinical Recurrence of Nipple Discharge (Secondary)

Adverse events

Time frame: Up to 6 months post treatment

• Sheldon Feldman, MD, Principal investigator, Montefiore Medical Center