Breast Discharge Infected Clinical Trial
Official title:
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
Verified date | November 2023 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | January 11, 2017 |
Est. primary completion date | January 11, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 ?nding on the pre-operative nipple smear - Have Gail Score >1.67 - Have had any subareolar or other surgery - Have active infections or in?ammation 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. |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center | Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Complete Ductoscopic Retrievals | 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. | 6 months | |
Secondary | Number of Patients With Cessation of Nipple Discharge | Therapeutic success will be determined by cessation after ductoscopic papillectomy (DP) in over 95% of enrolled patients with pathologic nipple discharge (PND) with a single papilloma. | Up to 2 weeks from the procedure | |
Secondary | Number of Patients With Clinical Recurrence of Nipple Discharge | Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years. | Up to 2 years |