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

NCT ID: NCT04568941

Last Updated: 2020-10-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-06-01

Brief Summary

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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

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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.

Conditions

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Breast Cancer Sentinel Lymph Node

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperative Vacuum-Assisted Biopsy

Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost.

Group Type EXPERIMENTAL

Vacuum-Assisted Biopsy

Intervention Type BEHAVIORAL

Vacuum-Assisted Biopsy

Preoperative Core Needle Biopsy

Preoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles.

Group Type EXPERIMENTAL

Core Needle Biopsy

Intervention Type BEHAVIORAL

Core Needle Biopsy

Intraoperative Excisional Biopsy

The tumor was excised intraoperatively.

Group Type EXPERIMENTAL

Intraoperative Excisional Biopsy

Intervention Type BEHAVIORAL

Intraoperative Excisional Biopsy

Interventions

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Vacuum-Assisted Biopsy

Vacuum-Assisted Biopsy

Intervention Type BEHAVIORAL

Core Needle Biopsy

Core Needle Biopsy

Intervention Type BEHAVIORAL

Intraoperative Excisional Biopsy

Intraoperative Excisional Biopsy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shandong Cancer Hospital and Institute

OTHER

Sponsor Role lead

Responsible Party

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Zhiyong Yu

Zhiyong Yu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhiyong Yu

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Zhiyong Yu, PhD

Role: CONTACT

86-13355312277

Chao Li, MD

Role: CONTACT

86-15665851082

Facility Contacts

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Zhiyong Yu, PhD

Role: primary

86053167626958 ext. 86053167626958

Chao Li, MD

Role: backup

86053167626958 ext. 86053167626958

References

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Yuan C, Wang X, Liu Z, Li C, Bian M, Shan J, Song X, Yu Z, Yu J. Preoperative tumor biopsy results in more detected sentinel nodes than intraoperative biopsy in breast cancer patients. World J Surg Oncol. 2020 Jul 21;18(1):178. doi: 10.1186/s12957-020-01942-4.

Reference Type RESULT
PMID: 32693797 (View on PubMed)

Related Links

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Other Identifiers

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ShandongCHI-13

Identifier Type: -

Identifier Source: org_study_id