Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
Primary Purpose
Breast Discharge Infected, Intraductal Papilloma of Breast
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ductoscopic papillomectomy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Discharge Infected focused on measuring ductoscopy, nipple discharge, breast, papilloma
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.
Sites / Locations
- Montefiore Medical Center
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ductoscopic papillomectomy
Arm Description
Ductoscopic papillomectomy to treat pathological nipple discharge
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of patients with cessation of nipple discharge
Therapeutic success will be determined by cessation after ductoscopic papillomectomy (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
Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years.
Full Information
NCT ID
NCT01901562
First Posted
July 13, 2013
Last Updated
August 3, 2023
Sponsor
Montefiore Medical Center
Collaborators
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT01901562
Brief Title
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
Official Title
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Study under oversight of Columbia IRB. Waiting on funding and collaborators
Study Start Date
September 27, 2013 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Columbia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 papillomectomy (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Discharge Infected, Intraductal Papilloma of Breast
Keywords
ductoscopy, nipple discharge, breast, papilloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ductoscopic papillomectomy
Arm Type
Experimental
Arm Description
Ductoscopic papillomectomy to treat pathological nipple discharge
Intervention Type
Device
Intervention Name(s)
Ductoscopic papillomectomy
Intervention Description
Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy
Primary Outcome Measure Information:
Title
Number of complete ductoscopic retrievals
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of patients with cessation of nipple discharge
Description
Therapeutic success will be determined by cessation after ductoscopic papillomectomy (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
Title
Number of patients with clinical recurrence of nipple discharge
Description
Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years.
Time Frame
Up to 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon Feldman, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
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