Identification and Preservation of Arm Lymphatics (DEPART)

Wuhan University

Status: Enrolling

Conditions: Breast Cancer Related Lymphedema

Treatments: Procedure: Identification and preservation of arm lymphatics (DEPART)

Study type: Interventional

Funder types: Other

Identifiers

NCT04446494

ZLYNXM202014

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Axillary dissection with DEPART technique

Experimental group

Description:

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.

Treatment:

Procedure: Identification and preservation of arm lymphatics (DEPART)

Standard axillary dissection

No Intervention group

Description:

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