TerminatedNot Applicable

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

Stopped: Could not identify collaborator and secure additional funding following transfer of study to Montefiore Medical Center

United States9 participantsStarted 2013-09-27

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Complete Ductoscopic Retrievals

Timeframe: 6 months

Trial details

NCT IDNCT01901562

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-11

Results submitted2023-10-16

View on ClinicalTrials.gov More Breast Discharge Infected trials