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

Randomized Controlled Trial of Comparison of Tumor Biopsy Method of Preoperative Vacuum-Assisted, Core Needle Versus Intraoperative Excisional Biopsy for Sentinel Lymph Node Biopsy in Breast Cancer

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04568941

Enrollment

600

Registered

2020-09-29

Start date

2020-11-01

Completion date

2021-06-01

Last updated

2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Sentinel Lymph Node

Keywords

Sentinel Lymph Node, vacuum-assisted biopsy, Core needle biopsy, Breast Cancer

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.

Interventions

BEHAVIORALVacuum-Assisted Biopsy

Vacuum-Assisted Biopsy

BEHAVIORALCore Needle Biopsy

Core Needle Biopsy

BEHAVIORALIntraoperative Excisional Biopsy

Intraoperative Excisional Biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Identification rates of sentinel lymph node biopsy	1 year	Identification rate of SLNB between three groups

Secondary

Measure	Time frame	Description
Identification numbers of sentinel lymph node biopsy	1 year	Identification numbers of SLNB between three groups
fase-negative rates of sentinel lymph node biopsy	1 year	fase-negative rates of SLNB between three groups

Countries

China

Contacts

Primary ContactZhiyong Yu, PhD

drzhiyongyu@aliyun.com86-13355312277

Backup ContactChao Li, MD

lichao19890305@126.com86-15665851082

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026