Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-29 @ 11:28 PM
Study NCT ID:
NCT03857932
Status:
RECRUITING
Last Update Posted:
2021-08-31
First Post:
2019-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study
Sponsor:
Shandong University
Organization:
Study Overview
Official Title:
Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
Status:
RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: