Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

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.

Official Title
-----------------
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

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Device: Cryo-assisted core needle biopsy
* Device: FNA


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arm, prospective, open label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryo-assisted core needle biopsy<br>Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially. | Device: Cryo-assisted core needle biopsy<br>* 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.<br>Device: FNA<br>* FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.<br>|
| Active Comparator: Fine needle aspiration alone<br>Patients undergo lymph node biopsy with FNA alone. | Device: FNA<br>* FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Immediate after biopsy specimen is evaluated by pathologists. | 
| Adverse effect of surgery | Hematoma, bleeding need , suture exposure and extrusion. | 4 weeks after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast neoplasms, Ultrasonography, Interventional, Biopsy, Large-Core Needle, Biopsy, Fine-Needle