Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
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 papillomectomy (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.
Pathologic Nipple Discharge
Device: Ductoscopic papillomectomy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge|
- Number of complete ductoscopic retrievals [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
- Number of patients with cessation of nipple discharge [ Time Frame: Up to 2 weeks from the procedure ] [ Designated as safety issue: Yes ]Over 95% of enrolled patients with pathologic nipple discharge (PND) with a single papilloma must have cessation after ductoscopic papillomectomy (DP) to achieve therapeutic success.
- Number of patients with clinical recurrence of nipple discharge [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Ductoscopic papillomectomy
Ductoscopic papillomectomy to treat pathological nipple discharge
Device: Ductoscopic papillomectomy
Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01901562
|Contact: Sheldon Feldman, MDfirstname.lastname@example.org|
|Contact: Jessica Segniemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Sheldon M Feldman, MD 212-305-9676 firstname.lastname@example.org|
|Principal Investigator: Sheldon M Feldman, MD|
|Sub-Investigator: Fatih Levent Balci, MD|
|Principal Investigator:||Sheldon Feldman, MD||CUMC|