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Slow recruiting rate.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryo-assisted core needle biopsy | Experimental | Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially. |
|
| Fine needle aspiration alone | Active Comparator | Patients undergo lymph node biopsy with FNA alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryo-assisted core needle biopsy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of biopsy | True positive rate measures the proportion of positives that are correctly identified by Core needle or FNA | Immediate after pathological lymph node stage is available |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | The true negative rate measures the proportion of negatives that are correctly identified. | Immediate after pathological lymph node stage is available. |
| Sample adequency | The specimen amount or quality for diagnosis is adequate or not evaluated by pathologists |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu Wang, MD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 10044 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Two arm, prospective, open label study
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| FNA | Device | FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia. |
|
| Immediate after biopsy specimen is evaluated by pathologists. |
| Adverse effect of surgery | Hematoma, bleeding need , suture exposure and extrusion. | 4 weeks after surgery. |
| D017437 |
| Skin and Connective Tissue Diseases |