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.
|Breast Discharge Infected Intraductal Papilloma of Breast||Device: Ductoscopic papillomectomy||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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 ]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 ]Therapeutic success will be determined by cessation after ductoscopic papillomectomy (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 [ Time Frame: Up to 2 years ]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 2018|
|Estimated Primary Completion Date:||July 2017 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01901562
|Contact: Sheldon Feldman, MDfirstname.lastname@example.org|
|Contact: Amanda Alonsoemail@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|
|Principal Investigator:||Sheldon Feldman, MD||Columbia University|