Breast Discharge Infected, Intraductal Papilloma of Breast
Conditions
Keywords
ductoscopy, nipple discharge, breast, papilloma
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 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.
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 spontaneous or easily expressible single duct nipple discharge, which contributes to 5% of referrals to breast surgeons. Patients with PND represent a diagnostic and therapeutic challenge for the surgical clinician. The most frequent causes of PND in these cases are intraductal papilloma (IP) in 36% to 66%, ductal carcinoma in situ (DCIS) in 3% to 20% and other benign causes in up to 23%. The evaluation of women with PND usually involves radiological(mammography, ultrasound, ducto (galacto)graphy and cytological (nipple smear, ductal lavage) examinations; however, each of these procedures has found to have low sensitivity and specificity. A ductoscope is an instrument which allows visualization of abnormalities and polypoid lesions within the ductal system with access via the nipple orifice to aid in evaluation of PND. Moreover, it is currently being used to improve localization of lesions in patients with PND. Ductoscopically guided excision is an improvement over standard surgical approaches with terminal duct excision which removes a large volume of tissue with potential cosmetic deformity and for young women may make breast feeding not possible. Ductoscopy also allows retrieval of intraductal cells for diagnostic purposes using brush cytology.
Interventions
DEVICEDuctoscopic papillectomy
Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy
Sponsors
Columbia University
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Complete Ductoscopic Retrievals | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Cessation of Nipple Discharge | Up to 2 weeks from the procedure | 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. |
| Number of Patients With Clinical Recurrence of Nipple Discharge | Up to 2 years | Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ductoscopic Papillectomy Ductoscopic papillectomy to treat pathological nipple discharge
Ductoscopic papillectomy: Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Excluded intraoperatively | 4 |
| Overall Study | Protocol Violation | 5 |
Baseline characteristics
| Characteristic | Ductoscopic Papillectomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 6 months
Population: Data related to the number of complete ductoscopic retrievals was not collected and analyzed.
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.
Time frame: Up to 2 weeks from the procedure
Population: Data related to the number of participants with cessation of nipple discharge after ductoscopic papillectomy was not collected and analyzed.
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.
Time frame: Up to 2 years
Population: Data related to the recurrence of nipple discharge was not collected and analyzed.