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Selective Omission of Sentinel Lymph Node Biopsy in Mastectomy for Ductal Carcinoma in Situ: Identifying Eligible Candidates

Upstaging and Lymph Node Metastasis Rate in Patients With Ductal Carcinoma in Situ Who Received Mastectomy Regarding the Necessary of Sentinel Lymph Node Biopsy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05961280
Enrollment
385
Registered
2023-07-27
Start date
2010-01-01
Completion date
2021-12-30
Last updated
2023-07-27

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

Conditions

Ductal Carcinoma in Situ

Brief summary

This study aimed to assess the prevalence of upgrade to invasive breast cancer and axillary lymph node metastasis in patients who were diagnosed with DCIS on biopsy and subsequently underwent mastectomy with axillary surgery to establish the need for SLNB. Furthermore, we explored the clinicopathologic features related to the upgrade to invasive breast cancer and axillary lymph node metastasis.

Interventions

PROCEDUREMastectomy with sentinel lymph node biopsy

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Women diagnosed with DCIS in preoperative biopsy samples obtained by core needle biopsy, vacuum-assisted breast biopsy, or excisional biopsy 2. Women underwent curative surgery for DCIS

Exclusion criteria

1. Patients who received breast-conserving surgery 2. Patients who had concurrent contralateral invasive breast cancer 3. Patients who were in case of ipsilateral breast tumor recurrence 4. Patients whose invasiveness was uncertain in the biopsy samples

Design outcomes

Primary

MeasureTime frameDescription
Axillary lymph node metastasis rateup to 2 weeks after surgeryOur primary objective was to identify the axillary lymph node metastasis rate in patients with DCIS at diagnosis who underwent mastectomy with axillary surgery.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026