Clinical trial · Interventional
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Could not identify collaborator and secure additional funding following transfer of study to Montefiore Medical Center
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Discharge Infected | — | UNRESOLVED | — |
| Intraductal Papilloma of Breast | Breast Intraductal Papilloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ductoscopic papillectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ductoscopic papillectomy
- description
- Ductoscopic papillectomy to treat pathological nipple discharge
- interventionNames
- Device: Ductoscopic papillectomy
Primary outcomes (1)
- measure
- Number of Complete Ductoscopic Retrievals
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (2)
- measure
- Number of Patients With Cessation of Nipple Discharge
- timeFrame
- Up to 2 weeks from the procedure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available