Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer

Overview

The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.

Full Title of Study: “Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 31, 2025

Detailed Description

AIM:Sentinel lymph node biopsy (SLNB) is the standard technique for patients with early stage breast cancer. The investigators conduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. And The investigators identify the true sentinel lymph nodes(SLNs) followed by lymphatic ducts during operation. The investigators aimed to identify the non-sentinel lymph node, and to investigate the relationship between upper extremity lymphatic drainage. The SLNB procedure could avoid unnecessary lymph node resection and reduce treatment-related sequela.

Arm1:

1. Participants received preoperative computed tomographic lymphography

2. Participants received sentinel lymph node biopsy(SLNB)

3. Participants received stained non-sentinel lymph node resection during SLNB

4. Participants received axillary reverse mapping dissection Arm2: Participants receive sentinel lymph node biopsy

Interventions

  • Procedure: Participants receive SLNB as well as non SLNs resection
    • Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection

Arms, Groups and Cohorts

  • Experimental: SLNB and non-slns resection
    • Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection
  • Experimental: SLNB group
    • Participants only receive SLNB

Clinical Trial Outcome Measures

Primary Measures

  • Disease free survival
    • Time Frame: Up to 10 years
    • Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.

Secondary Measures

  • Overall survival
    • Time Frame: Up to 10 years
    • Time from randomization to death from any cause, assessed up to 10 years.

Participating in This Clinical Trial

Inclusion Criteria

1. histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy

2. abnormal para-sentinel lymph node was found by ultrasound examination

3. ultrasound-guided fine needle aspiration cytology of these nodes were performed

4. the result of fine needle aspiration cytology was negative (no tumour cell was found)

5. participants planed to perform SLNB

Exclusion Criteria

1. pathological diagnosed ductal carcinoma in situ by excisional biopsy

2. the result of fine needle aspiration cytology was positive

3. participants has received neo-adjuvant system therapy

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Qifeng Yang, Professor – Shandong University
  • Overall Official(s)
    • Qifeng Yang, Principal Investigator, Qilu Hospital, Shandong University
  • Overall Contact(s)
    • Qifeng Yang, +8618560085168, qifengy_sdu@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.