Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm, prospective, open label study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cryo-assisted core needle biopsy

Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.

Group Type EXPERIMENTAL

Cryo-assisted core needle biopsy

Intervention Type 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.

FNA

Intervention Type DEVICE

FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.

Fine needle aspiration alone

Patients undergo lymph node biopsy with FNA alone.

Group Type ACTIVE_COMPARATOR

FNA

Intervention Type DEVICE

FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.

Interventions

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Cryo-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.

Intervention Type DEVICE

FNA

FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed invasive breast cancer.
* With axillary lymph node with thickened cortex.
* Planned for sentinel lymph node biopsy or axillary clearance.