Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Disease free survival
Study Overview
Brief Summary
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.
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：
- Participants received preoperative computed tomographic lymphography
- Participants received sentinel lymph node biopsy（SLNB）
- Participants received stained non-sentinel lymph node resection during SLNB
- Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
- •abnormal para-sentinel lymph node was found by ultrasound examination
- •ultrasound-guided fine needle aspiration cytology of these nodes were performed
- •the result of fine needle aspiration cytology was negative (no tumour cell was found)
- •participants planed to perform SLNB
Exclusion Criteria
- •pathological diagnosed ductal carcinoma in situ by excisional biopsy
- •the result of fine needle aspiration cytology was positive
- •participants has received neo-adjuvant system therapy
Outcomes
Primary Outcomes
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 Outcomes
- Overall survival(Up to 10 years)
Investigators
Qifeng Yang
Professor
Shandong University