Breast Cancer
Conditions
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： 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
PROCEDUREParticipants 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
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 10 years | Time from randomization to death from any cause, assessed up to 10 years. |
Countries
China
Contacts
Primary ContactQifeng Yang
Backup ContactXiaoyan Li
Outcome results
None listed