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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01901562
Recruitment Status : Recruiting
First Posted : July 17, 2013
Last Update Posted : July 9, 2018
Information provided by (Responsible Party):
Sheldon Feldman, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Discharge Infected Intraductal Papilloma of Breast Device: Ductoscopic papillomectomy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
Study Start Date : September 2013
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Ductoscopic papillomectomy
Ductoscopic papillomectomy to treat pathological nipple discharge
Device: Ductoscopic papillomectomy
Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy

Primary Outcome Measures :
  1. Number of complete ductoscopic retrievals [ Time Frame: 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 Outcome Measures :
  1. Number of patients with cessation of nipple discharge [ Time Frame: Up to 2 weeks from the procedure ]
    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.

  2. Number of patients with clinical recurrence of nipple discharge [ Time Frame: Up to 2 years ]
    Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01901562

Contact: Sheldon Feldman, MD 212-305-9676
Contact: Amanda Alonso

United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Sheldon M Feldman, MD    212-305-9676   
Principal Investigator: Sheldon M Feldman, MD         
Sponsors and Collaborators
Sheldon Feldman
Principal Investigator: Sheldon Feldman, MD Columbia University

Responsible Party: Sheldon Feldman, Chief, Breast Surgical Oncology, Montefiore Medical Center Identifier: NCT01901562     History of Changes
Other Study ID Numbers: AAAK3900
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

Keywords provided by Sheldon Feldman, Montefiore Medical Center:
nipple discharge

Additional relevant MeSH terms:
Papilloma, Intraductal
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lactation Disorders
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Neoplasms, Ductal, Lobular, and Medullary