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Association of suspicious axillary node and sentinel node in breast cancer to minimizing axillary surgery, prospective cohort study

Phase 3
Completed
Conditions
Breast cancer, early breast cancer, locally advance breast cancer
Breast cancer, Sentinel lymph node biopsy, Targeted axillary dissection, Axillary lymph node dissection
Registration Number
TCTR20230725004
Lead Sponsor
Ramathibodi hospital Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
29
Inclusion Criteria

all women aged more than 18 years with pathologically confirmed invasive breast cancer with early stage cT1-2N0-1 M0 and suspicious nodes detected by ultrasonography or mammography with surgery upfront or breast cancer stage cT1-4N2M0, cT3-4N1M0, or cT1-2N0-1M0 who received neoadjuvant systemic treatment with suspicious nodes detected by ultrasonography or mammography and underwent surgery in the Breast and Endocrine Unit, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Thailand, between January 2021 and December 2022

Exclusion Criteria

prior cancer, ineligibility for FNA or CNB of the axilla, or allergies to nickel or titanium

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
whether a suspicious node was a sentinel node by correlating the suspected axillary lymph nodes at 2 months after end of the intervention Intra operative finding of clip suspicious node in sentinel node (Number, percent)
Secondary Outcome Measures
NameTimeMethod
accuracy of FNA of suspicious nodes at 2 months after end of the intervention Compare number of intra operative finding of clip suspicious node in sentinel node (Number, percent),Loss clip at 2 months after end of the intervention Number of operation that cannot identified clip in specimen (Number, percent)
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