Breast Cancer Clinical Trial
Official title:
Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
The purpose of the study is to estimate the diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer, and also to compare between ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with breast cancer.
Axillary lymph node status is an extremely important prognostic factor in the assessment and
treatment evaluation of patients with newly diagnosed breast cancer. Historically, axillary
lymph node dissection (ALND) has been the reference standard for diagnosis and staging.
However, this procedure can cause numerous postoperative problems, such as lymphedema , pain,
impaired shoulder mobility and arm weakness. Furthermore, in this era of mammographic
screening, axillary lymph node dissection yields negative results in 80%-85% of patients with
T1 cancer.
Therefore, in recent years, sentinel lymph node biopsy (SNB) has replaced axillary dissection
for lymph node staging at major medical centers. However, there are some practical issues to
be resolved. For example, radiotracer distribution can be slow or faulty, valuable operating
room time is expended, and pathologists must make quick decisions based on the analysis of
frozen sections or there is the need to undergo two surgical interventions (i.e., removal of
primary tumor and SNB, and in a next step completion ALND). If nodal positivity could be
proven and documented preoperatively, sentinel lymph node biopsy could be bypassed and a
decision will be made to perform axillary dissection, which is the standard of care in most
node-positive patients.
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