NCT03857932

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

Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-02-28
• Last updated: 2021-08-31

Locations

1 site across 1 country: China