Comparison of the Accuracy and Safety of Biopsy in Suspicious Axillary Lymph Nodes With a Crypo-assisted Stick Freeze Biopsy Device or Fine Needle Aspiration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Sensitivity of biopsy
Study Overview
Brief Summary
Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. This prospective study is to compare the performance of a crpo-assisted core biopsy with FNA.
Detailed Description
This prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (Cassi II, USA) compared with FNA for biopsy of intermediately suspicious lymph nodes. Eligible patients would be randomized to one of two arms by 1:2 : Core with FNA or FNA alone. The diagnostic accuracy and adverse outcome of core and FNA would be compared.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed invasive breast cancer.
- •With axillary lymph node with thickened cortex.
- •Planned for sentinel lymph node biopsy or axillary clearance.
Exclusion Criteria
- •Nodes ultrasonographically normal.
- •Nodes with hilar displacement .
- •Palpable matted nodes.
Arms & Interventions
Cryo-assisted core needle biopsy
Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.
Intervention: Cryo-assisted core needle biopsy (Device)
Cryo-assisted core needle biopsy
Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.
Intervention: FNA (Device)
Fine needle aspiration alone
Patients undergo lymph node biopsy with FNA alone.
Intervention: FNA (Device)
Outcomes
Primary Outcomes
Sensitivity of biopsy
Time Frame: Immediate after pathological lymph node stage is available
True positive rate measures the proportion of positives that are correctly identified by Core needle or FNA
Secondary Outcomes
- Adverse effect of surgery(4 weeks after surgery.)
- Sample adequency(Immediate after biopsy specimen is evaluated by pathologists.)
- Specificity(Immediate after pathological lymph node stage is available.)
Investigators
Houpu Yang
Principal Investigator
Peking University People's Hospital