Identification and Preservation of Arm Lymphatics (DEPART)
Breast Cancer Related Lymphedema
About this trial
This is an interventional prevention trial for Breast Cancer Related Lymphedema focused on measuring breast cancer, axillary lymph node dissection, lymphedema
Eligibility Criteria
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.
Sites / Locations
- Zhongnan Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Axillary dissection with DEPART technique
Standard axillary dissection
In the experimental group, 1 ml (2.5 mg) indocyanine green (ICG) and methylene blue (MB) was intradermally injected into the internal bicipital sulcus of ipsilateral arm. During axillary dissection, the identified arm sentinel nodes were carefully injected with 0.1 ml methylene blue (MB) using a 1-cc syringe with a 32-gauge needle. MB could then flow from the nodes along several lymphatic channels toward the infraclavicular nodes. Subsequent-echelon nodes and lymphatics were identified. Sentinel lymph nodes (SLNs) were removed after the identification of the arm sentinel nodes and the procedure of MB injection. When patients harbored positive SLNs, axillary lymph node dissection (ALND) was performed subsequently. All discernible arm lymphatics and lymph nodes were preserved, except that gross arm lymph nodes (major axis larger than 10 mm or node firm on palpation) were sent for immediate partial frozen section (pFS) to determine their resection during ALND.
In the control group (no intervention), ALND was performed with complete resection of at least Berg's levels I and II. Resection of level III was performed only in cases with gross disease in level II and/or III