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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
135
Rotational core needle biopsy would be done under local anesthesia. A small incision would be made in the axilla and core needle biopsy be performed using a special cryo-assisted stick freeze device (Cassi II, Scion Medical Technologies, USA). The cytological and histological specimens would be sent for diagnosis.
FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Sensitivity of biopsy
True positive rate measures the proportion of positives that are correctly identified by Core needle or FNA
Time frame: Immediate after pathological lymph node stage is available
Specificity
The true negative rate measures the proportion of negatives that are correctly identified.
Time frame: Immediate after pathological lymph node stage is available.
Sample adequency
The specimen amount or quality for diagnosis is adequate or not evaluated by pathologists
Time frame: Immediate after biopsy specimen is evaluated by pathologists.
Adverse effect of surgery
Hematoma, bleeding need , suture exposure and extrusion.
Time frame: 4 weeks after surgery.
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