Identification and Preservation of Arm Lymphatics

Breast Cancer Related Lymphedema Clinical Trial

— DEPART  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446494
• Other study ID #: ZLYNXM202014
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: December 2020
• Source: Wuhan University
• Contact: Qianqian Yuan, MD.
• Phone: +8613026322297
• Email: Yuanqq11[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• Identification 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.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (1)

Yuan Q, Wu G, Xiao SY, Hou J, Ren Y, Wang H, Wang K, Zhang D. Identification and Preservation of Arm Lymphatic System in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Randomized Clinical Trial. Ann Surg Oncol. 2019 Oct;26(11):34 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of arm lymphedema	A difference in volume between the arms < 10% was defined as lymphedema.	Up to 2 years
Secondary	Rate of locoregional recurrence	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.	5-year estimate reported after a median follow-up of 60 months
Secondary	Rate of distant metastasis	Cancer cells from breast metastasized to other organs.	5-year estimate reported after a median follow-up of 60 months