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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: Randomised test intervention vs standardized intervention, non‐blinded (Phase III) CONDITION: Cancer: Breast ; Cancer PRIMARY OUTCOME: 1. Successful visualisation of lesions in the duct endoscopy group correlating to pathological findings; 2. Size of the tissue resection in the DE versus no DE group SECONDARY OUTCOME: Not provided at time of registration 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
Epistemonikos ID: 1dc0a4483643cd53a738d129d3d0cc7c9bbc4484
First added on: Aug 21, 2024