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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04446494
Other study ID # ZLYNXM202014
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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