Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study

Shandong University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Participants receive SLNB as well as non SLNs resection

Study type: Interventional

Funder types: Other

Identifiers

NCT03857932

HECT004

Details and patient eligibility

About

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 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

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

SLNB and non-slns resection

Experimental group

Description:

1. Participants only receive SLNB 2. preoperative CT lymphography 3. SLNB with stained non-SLN resection 4. SLNB with ARM dissection

Treatment:

Procedure: Participants receive SLNB as well as non SLNs resection

SLNB group

Experimental group

Description:

Participants only receive SLNB

Treatment:

Procedure: Participants receive SLNB as well as non SLNs resection