Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04446494
Status:
RECRUITING
Last Update Posted:
2020-12-10
First Post:
2020-06-21
Brief Title:
Identification and Preservation of Arm Lymphatics
Sponsor:
Wuhan University
Organization:
Wuhan University
Study Overview
Official Title:
Identification and Preservation of Arm Lymphatics DEPART in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events A Multicenter Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2020-12
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:
DEPART
Brief Summary:
Controversy in axillary reverse mapping in axillary lymph node dissection ALND possibly results from incomplete recognition of the arm lymphatic system ALS and its compromise to oncological safety The iDEntification and Preservation of ARm lymphaTics DEPART technique facilitates complete identification of ALS therefore its use may decrease the occurrence of arm lymphedema This study aimed to examine the arm lymphedema rate locoregional recurrence and feasibility to perform DEPART in ALND
In the study group indocyanine green and methylene blue MB were utilized to identify arm sentinel nodes and 01 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive Arm lymphedema local recurrence regional recurrence and distant metastasis were recorded at different follow-up examinations
In the study group indocyanine green and methylene blue MB were utilized to identify arm sentinel nodes and 01 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive Arm lymphedema local recurrence regional recurrence and distant metastasis were recorded at different follow-up examinations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None