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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Sheldon Feldman, Columbia University
ClinicalTrials.gov Identifier:
NCT01901562
First received: July 13, 2013
Last updated: April 19, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Pathologic Nipple Discharge
Solitary Papilloma
Device: Ductoscopic papillomectomy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of complete ductoscopic retrievals [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 2 weeks from the procedure ] [ Designated as safety issue: Yes ]
    Over 95% of enrolled patients with pathologic nipple discharge (PND) with a single papilloma must have cessation after ductoscopic papillomectomy (DP) to achieve therapeutic success.

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


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ductoscopic papillomectomy
Ductoscopic papillomectomy to treat pathological nipple discharge
Device: Ductoscopic papillomectomy
Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901562

Contacts
Contact: Sheldon Feldman, MD 212-305-9676 sf2388@columbia.edu
Contact: Amiya Vaz av2454@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Sheldon M Feldman, MD    212-305-9676    sf2388@columbia.edu   
Principal Investigator: Sheldon M Feldman, MD         
Sub-Investigator: Fatih Levent Balci, MD         
Sponsors and Collaborators
Sheldon Feldman
Investigators
Principal Investigator: Sheldon Feldman, MD CUMC
  More Information

No publications provided

Responsible Party: Sheldon Feldman, Chief, MD, Ass. Prof., FACS, Columbia University
ClinicalTrials.gov Identifier: NCT01901562     History of Changes
Other Study ID Numbers: AAAK3900
Study First Received: July 13, 2013
Last Updated: April 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
ductoscopy
nipple discharge
breast
papilloma

Additional relevant MeSH terms:
Papilloma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 24, 2014