Breast Neoplasms
Conditions
Keywords
breast neoplasms, Ultrasonography, Interventional, Biopsy, Large-Core Needle, Biopsy, Fine-Needle
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.
Interventions
DEVICECryo-assisted core needle biopsy
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.
DEVICEFNA
FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Two arm, prospective, open label study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of biopsy | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect of surgery | 4 weeks after surgery. | Hematoma, bleeding need , suture exposure and extrusion. |
| Specificity | Immediate after pathological lymph node stage is available. | The true negative rate measures the proportion of negatives that are correctly identified. |
| Sample adequency | Immediate after biopsy specimen is evaluated by pathologists. | The specimen amount or quality for diagnosis is adequate or not evaluated by pathologists |
Countries
China
Outcome results
None listed