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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Discharge Infected, Intraductal Papilloma of Breast

Intervention / Treatment
-----------------
* Device: Ductoscopic papillectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ductoscopic papillectomy<br>Ductoscopic papillectomy to treat pathological nipple discharge | Device: Ductoscopic papillectomy<br>* Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ductoscopy, nipple discharge, breast, papilloma