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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Discharge Infected; Intraductal Papilloma of Breast
• Intervention / Treatment: Device: Ductoscopic papillectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ductoscopic papillectomy; Ductoscopic papillectomy to treat pathological nipple discharge	Device: Ductoscopic papillectomy; Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Columbia University
• Investigators: Principal Investigator: Sheldon Feldman, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2013
• Primary Completion (Actual): January 11, 2017
• Study Completion (Actual): January 11, 2017

Study Registration Dates

• First Submitted: July 13, 2013
• First Submitted That Met QC Criteria: July 13, 2013
• First Posted (Estimated): July 17, 2013

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: breast; papilloma; ductoscopy; nipple discharge
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Neoplasms, Squamous Cell; Neoplasms, Ductal, Lobular, and Medullary; Lactation Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Papilloma; Papilloma, Intraductal; Galactorrhea
• Other Study ID Numbers: AAAK3900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO