Identification and Preservation of Arm Lymphatics

  • STATUS
    Recruiting
  • End date
    Sep 30, 2025
  • participants needed
    1200
  • sponsor
    Wuhan University
Updated on 26 January 2021
cancer
breast cancer
indocyanine green
mastectomy
axillary lymph node dissection

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 0.1 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.

Details
Condition Lymphedema, Lymphedema, Breast Cancer Lymphedema
Treatment Identification and preservation of arm lymphatics (DEPART)
Clinical Study IdentifierNCT04446494
SponsorWuhan University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 18 years or older with T1-3 invasive breast cancer
Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast
Patients who underwent mastectomy with a positive sentinel lymph node (SLN)
Patients who underwent breast-conserving surgery containing more than two positive SLNs

Exclusion Criteria

Neoadjuvant chemotherapy
Previous history of breast cancer
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