Randomized Controlled Trial of Comparison of Tumor Biopsy Method of Preoperative Vacuum-Assisted, Core Needle Versus Intraoperative Excisional Biopsy for Sentinel Lymph Node Biopsy in Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Identification rates of sentinel lymph node biopsy
Study Overview
Brief Summary
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.
Detailed Description
OBJECTIVES:
Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods.
Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods.
OUTLINE:
The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinically lymph node negative breast cancer patients T1-T3
Exclusion Criteria
- •history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients
Outcomes
Primary Outcomes
Identification rates of sentinel lymph node biopsy
Time Frame: 1 year
Identification rate of SLNB between three groups
Secondary Outcomes
- fase-negative rates of sentinel lymph node biopsy(1 year)
- Identification numbers of sentinel lymph node biopsy(1 year)
Investigators
Zhiyong Yu
Zhiyong Yu
Shandong Cancer Hospital and Institute