A randomised controlled trial of duct endoscopy as an adjunct to standard surgery for pathological nipple discharge

Phase 3

Completed

• Conditions: Cancer: Breast; Cancer

• Registration Number: ISRCTN45106315
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. 100 RMH female patients undergoing duct excision biopsy for the routine management of PND with symptoms of either spontaneous symptomatic discharge from a single duct
2. Patients with bloodstained nipple discharge or abnormal cytology of the duct fluid
3. Routine preoperative screening: mammogram and ultrasound, where appropriate, in accordance with the breast unit protocol
4. Have not had previous periareolar incisions or surgical biopsy in the same quadrant as the target lesion
5. Have intact nipples
6. Have an ECOG score of 0-1
7. Able to give informed consent

Exclusion Criteria

1. Currently pregnant or pregnant within the past 6 months
2. Currently lactating or lactated within the past 6 months
3. Have received chemotherapy within the past 6 months
4. Have an active infection in the breast
5. Have a previous history of breast cancer (including invasive carcinoma, Paget?s disease and DCIS)
6. Have silicone injections or breast implants (pre-pectoral) that disrupt the ductal architecture of the breast
7. Have prior breast surgery that may cause the ductal system not to communicate with the nipple, as determined by the clinician
8. Be unwilling or unable to provide written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified