Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer

Not Applicable

• Conditions: Sentinel Lymph Node; Breast Cancer
• Interventions: Behavioral: Vacuum-Assisted Biopsy; Behavioral: Core Needle Biopsy; Behavioral: Intraoperative Excisional Biopsy

• Registration Number: NCT04568941
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.

Detailed Description

OBJECTIVES:

Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods.

Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods.

OUTLINE:

The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.

Study Timeline

• Study First Submitted: 2020-09-26
• Study First Submitted QC: 2020-09-26
• Study First Posted: 2020-09-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-24
• Last Update Posted: 2020-10-27
• Study Start: 2020-11-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• clinically lymph node negative breast cancer patients T1-T3

Exclusion Criteria

• history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative Vacuum-Assisted Biopsy	Vacuum-Assisted Biopsy	Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost.
Preoperative Core Needle Biopsy	Core Needle Biopsy	Preoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles.
Intraoperative Excisional Biopsy	Intraoperative Excisional Biopsy	The tumor was excised intraoperatively.

Primary Outcome Measures

Name	Time	Method
Identification rates of sentinel lymph node biopsy	1 year	Identification rate of SLNB between three groups

Secondary Outcome Measures

Name	Time	Method
fase-negative rates of sentinel lymph node biopsy	1 year	fase-negative rates of SLNB between three groups
Identification numbers of sentinel lymph node biopsy	1 year	Identification numbers of SLNB between three groups

Trial Locations

Locations (1)

Zhiyong Yu; 🇨🇳 Jinan, Shandong, China