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

ISRCTN	ISRCTN45106315
DOI	https://doi.org/10.1186/ISRCTN45106315
Secondary identifying numbers	N0258175375

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Mr Gerald Gui
Scientific

Breast Diagnostic Unit
Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Phone	+44 (0)20 7487 5558
Email	gerald.gui@rmh.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of duct endoscopy as an adjunct to standard surgery for pathological nipple discharge
Study acronym	INTEND II
Study objectives	To clarify the future role of the intraduct approach in a systematic manner by a randomised controlled trial that would establish whether this approach should be encouraged or disparaged.
Ethics approval(s)	The Royal Marsden Local Research Ethics Committee (LREC), 20/03/2006, ref: 06/Q0801/29
Health condition(s) or problem(s) studied	Cancer: Breast
Intervention	Randomised test intervention vs standardized intervention, non-blinded (Phase III)
Intervention type	Other
Primary outcome measure	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 measures	Not provided at time of registration
Overall study start date	01/03/2006
Completion date	31/03/2011

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	100
Key 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
Key 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, Pagets 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
Date of first enrolment	01/03/2006
Date of final enrolment	31/03/2011

Breast Diagnostic Unit

London
SW3 6JJ
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

15/03/2017: No publications found in PubMed, verifying study status with principal investigator.