Identification and Preservation of Arm Lymphatics

Not Applicable

Recruiting

• Conditions: Breast Cancer Related Lymphedema

• Registration Number: NCT04446494
• Lead Sponsor: Wuhan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-20
• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-10
• Primary Completion: 2021-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of arm lymphedema	Up to 2 years	A difference in volume between the arms \< 10% was defined as lymphedema.

Secondary Outcome Measures

Name	Time	Method
Rate of distant metastasis	5-year estimate reported after a median follow-up of 60 months	Cancer cells from breast metastasized to other organs.
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.

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China