Breast Cancer Related Lymphedema
Conditions
Keywords
breast cancer, axillary lymph node dissection, lymphedema
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 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.
Interventions
PROCEDUREIdentification and preservation of arm lymphatics (DEPART)
Indocyanine green was 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.
Sponsors
Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of arm lymphedema | Up to 2 years | A difference in volume between the arms \< 10% was defined as lymphedema. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of locoregional recurrence | 5-year estimate reported after a median follow-up of 60 months | Locoregional recurrence included local recurrence and regional recurrence. Local recurrence was defined as chest wall recurrence of breast cancer, and regional recurrence was defined as the axilla recurrence of breast cancer. |
| Rate of distant metastasis | 5-year estimate reported after a median follow-up of 60 months | Cancer cells from breast metastasized to other organs. |
Countries
China
Contacts
Primary ContactQianqian Yuan, MD.
Outcome results
None listed