Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Wuhan University
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Rate of distant metastasis
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
It has been hypothesized that damaged arm lymphatic drainage is associated with the arm lymphedema after axillary lymph node dissection (ALND). However, the majority of breast cancer patients with complete ALND has not suffered from arm lymphedema, which appears to be due to the residual arm lymph nodes that has not been removed in the axillary dissection. With the compensation of the residual arm lymph flow above the level of axillary vein, the arm lymphatic drainage could keep balance and remain normal function.
This arm lymphedema prediction model that included the protective factor, the proportion of arm lymph flow above the level of axillary vein, allows intraoperative intervention to be performed for the high-risk group. The arm lymphatics of these distinguished patients would be preserved to eliminate the occurrence of arm lymphedema in this study.
Investigators
Gaosong Wu, Ph D, MD
Director
Wuhan University
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.
Outcomes
Primary Outcomes
Rate of distant metastasis
Time Frame: Up to 5 years
Cancer cells from breast metastasized to other organs.
Rate of arm lymphedema
Time Frame: Up to 5 years
A difference in volume between the arms \< 10% was defined as lymphedema
Rate of locoregional recurrence
Time Frame: Up to 5 years
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