Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

Breast Neoplasms Clinical Trial

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

Status Suspended

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT03130946
• Study type: Interventional
• Source: Peking University People's Hospital
• Status: Suspended
• Phase: N/A
• Start date: May 1, 2017
• Completion date: December 1, 2023