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Duct endoscopy in the evaluation of breast cancer and surgical margins

Duct endoscopy in the evaluation of breast cancer and surgical margins

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82827389
Enrollment
176
Registered
2006-09-29
Start date
2006-02-09
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer: Breast Cancer Malignant neoplasm of breast

Interventions

Test intervention vs standardized intervention

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female patients undergoing wide local excision determined by standard criteria for the management of needle biopsy-diagnosed DCIS, or clinical stage 1 or 2 breast cancer 2. Tumour <3cm, have not had previous periareolar incisions or surgical biopsy in the same quadrant as the target lesion, have intact nipples, have an ECOG score of 0-1 3. Able to give consent

Exclusion criteria

Exclusion criteria: Subjects may not participate in the clinical trial if they meet ANY of the following criteria: 1. Currently 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 silicone injections or breast implants (pre-pectoral) that disrupt the ductal architecture of the breast 6. Have prior breast surgery that may cause the ductal system not to communicate with the nipple, as determined by the clinician 7. Be unwilling or unable to provide written informed consent.

Design outcomes

Primary

MeasureTime frame
Duct endoscopy assisted determination of excision margins in breast conservation surgery and its effect on re-excision rates.

Secondary

MeasureTime frame
Added September 2008: laboratory studies on the ductal lavage material obtained.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026