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 range18 Years

SexFEMALE

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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.

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