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

Not Applicable

Terminated

Brief Summary: In this prospective clinical trial, patients who sign an approved informed consent for ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the study. Consented patients who have been diagnosed with a solitary papilloma within the discharging duct will be recruited to have interventional ductoscopy.

Patients who are identified ductoscopically with a solitary non-sessile papilloma will undergo an attempted ductoscopic papillectomy (DP). Patients with ductoscopic findings other than single non-sessile papilloma will undergo standard ductoscopically guided microductectomy. The investigators will investigate whether the ductoscopic basket can be used as a safe endoscopic extraction instrument without adverse events. Histopathological evaluation will be performed to confirm the ductoscopic diagnosis and to determine the existence of any malignant tissue.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Ductoscopic papillectomy	Ductoscopic papillectomy	Ductoscopic papillectomy to treat pathological nipple discharge

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Locations (2): Columbia University Medical Center
🇺🇸
New York, New York, United States
Montefiore Medical Center
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Bronx, New York, United States