Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.

Not Applicable

• Conditions: Breast Cancer
• Interventions: Procedure: Ultrasound-guided axillary lymph nodes FNAC and\or CNB.

• Registration Number: NCT03681418
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-21
• Last Update Submitted: 2018-09-21
• Study First Posted: 2018-09-24
• Last Update Posted: 2018-09-24
• Study Start: 2018-10
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not.

Exclusion Criteria

• Patients who had previously undergone axillary surgery.
• Patients with metastatic disease and not planned for axillary surgery.
• Patients with a preoperative diagnosis of a benign lesion or ductal carcinoma in situ.
• Patients with severe uncorrectable bleeding diathesis.
• Patients refused to sign consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with operable breast cancer	Ultrasound-guided axillary lymph nodes FNAC and\or CNB.	Ultrasound-guided axillary lymph nodes FNAC and\\or CNB.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer.	Baseline.	Accuracy will be determined by comparing the results of ultrasound-guided axillary lymph node biopsy to the gold standard which is the final pathological results from sentinel lymphadenectomy or axillary lymph node dissection.

Secondary Outcome Measures

Name	Time	Method
Accuracy of 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 a recent diagnosis of ipsilateral breast cancer.	Baseline.	Ultrasound-guided fine needle aspiration and\\or core needle biopsy of axillary lymph node of the patient.