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Clinical Trials in South Korea / NCT05912569
Recruiting Not applicable

Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS

NCT05912569 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2023-06-13
Last updated
2025-01-31

Condition(s) studied

DCIS

Investigational drug(s) / intervention(s)

Delay sentinel node biopsy

Delay sentinel node biopsy: In the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. I

Study summary

In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery.

primary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.

addendum) The previously documented Breast-Conserving Surgery has been corrected to reflect the accurate procedure of Total Mastectomy.

Eligibility

Sex
ALL
Min age
20 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged 20 to 75 years old. * Patients diagnosed with DCIS through histological examination. * Patients undergoing mastectomy Exclusion Criteria: * In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions. * In cases where imaging tests or physical examinations suggest possible lymph node metastasis. * In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure. * Pregnant patients.

Primary outcome measure(s)

  • success rate — 2 weeks later
    The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05912569 on ClinicalTrials.gov ↗ ← All trials in South Korea