Status:
TERMINATED
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Columbia University
Conditions:
Breast Discharge Infected
Intraductal Papilloma of Breast
Eligibility:
FEMALE
18+ years
Phase:
NA
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 patie...
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 spontan...
Eligibility Criteria
Inclusion
- Be female
- Have pathologic (unilateral/uniductal) nipple discharge
- Been diagnosed with single papilloma
- Be over 18 years of age
- Sign the informed consent form
Exclusion
- 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.
Key Trial Info
Start Date :
September 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01901562
Start Date
September 27 2013
End Date
January 11 2017
Last Update
November 9 2023
Active Locations (2)
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1
Columbia University Medical Center
New York, New York, United States, 10032
2
Montefiore Medical Center
The Bronx, New York, United States, 10467