Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
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|ClinicalTrials.gov Identifier: NCT01901562|
Recruitment Status : Active, not recruiting
First Posted : July 17, 2013
Last Update Posted : April 13, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Discharge Infected Intraductal Papilloma of Breast||Device: Ductoscopic papillomectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge|
|Actual Study Start Date :||September 27, 2013|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Ductoscopic papillomectomy
Ductoscopic papillomectomy to treat pathological nipple discharge
Device: Ductoscopic papillomectomy
Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901562
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Sheldon Feldman, MD||Montefiore Medical Center|