Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Papilloma

Galactorrhea

Papilloma, Intraductal

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lactation Disorders

Puerperal Disorders

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Breast Diseases

Skin Diseases

Ductoscopic papillectomy to treat pathological nipple discharge

Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy

Ductoscopic papillectomy

Sheldon Feldman, MD

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.

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.

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

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.

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.

Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years.

Columbia University

Montefiore Medical Center

Five participants were excluded for not meeting protocol inclusion/exclusion criteria (i.e., screen failed) immediately following enrollment and did not participate in the study procedure.

Four participants proceeded with the procedure. All four participants did not complete the study as the surgeon was unable to cannulate the ductal system or the patient was found to not have a solitary papilloma.

Ductoscopic papillectomy to treat pathological nipple discharge

Ductoscopic papillectomy: Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy

Ductoscopic Papillectomy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Sheldon Feldman, Chief Breast Surgery and Breast Surgery Oncology

Data related to the number of complete ductoscopic retrievals was not collected and analyzed.

Number of Complete Ductoscopic Retrievals

Data related to the number of participants with cessation of nipple discharge after ductoscopic papillectomy was not collected and analyzed.

Number of Patients With Cessation of Nipple Discharge

Data related to the recurrence of nipple discharge was not collected and analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge	NCT01901562	Breast Discharg... Intraductal Pap...	Ductoscopic pap...	18 Years -	Montefiore Medical Center
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge	NCT01901562	Breast Discharg... Intraductal Pap...	Ductoscopic pap...	18 Years -	Montefiore Medical Center

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