Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

Not Applicable

Suspended

• Conditions: Breast Neoplasms
• Interventions: Device: Cryo-assisted core needle biopsy; Device: FNA

• Registration Number: NCT03130946
• Lead Sponsor: Peking University People's Hospital

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 Timeline

• Study First Submitted: 2017-04-23
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-27
• Study Start: 2017-05-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryo-assisted core needle biopsy	Cryo-assisted core needle biopsy	Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.
Fine needle aspiration alone	FNA	Patients undergo lymph node biopsy with FNA alone.
Cryo-assisted core needle biopsy	FNA	Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse effect of surgery	4 weeks after surgery.	Hematoma, bleeding need , suture exposure and extrusion.
Sample adequency	Immediate after biopsy specimen is evaluated by pathologists.	The specimen amount or quality for diagnosis is adequate or not evaluated by pathologists
Specificity	Immediate after pathological lymph node stage is available.	The true negative rate measures the proportion of negatives that are correctly identified.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China