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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2021

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

  • Behavioral: Vacuum-Assisted Biopsy
    • Vacuum-Assisted Biopsy
  • Behavioral: Core Needle Biopsy
    • Core Needle Biopsy
  • Behavioral: Intraoperative Excisional Biopsy
    • Intraoperative Excisional Biopsy

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Identification rates of sentinel lymph node biopsy
    • Time Frame: 1 year
    • Identification rate of SLNB between three groups

Secondary Measures

  • Identification numbers of sentinel lymph node biopsy
    • Time Frame: 1 year
    • Identification numbers of SLNB between three groups
  • fase-negative rates of sentinel lymph node biopsy
    • Time Frame: 1 year
    • fase-negative rates of SLNB between three groups

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong Cancer Hospital and Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhiyong Yu, Zhiyong Yu – Shandong Cancer Hospital and Institute
  • Overall Contact(s)
    • Zhiyong Yu, PhD, 86-13355312277, drzhiyongyu@aliyun.com

Citations Reporting on Results

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.

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