Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Contact Information
Primary
Qianqian Yuan, M.D.
Yuanqq11@whu.edu.cn
13026322297
Time Frame
Start Date: 2020-12-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 600
Treatments
Experimental: Axillary surgery based on lymphedema prediction nomogram
Based on the intraoperative lymphedema prediction nomogram, individualized treatment was recommended to breast cancer patients with different level of risk. For patients with low possibility of developing breast cancer related lymphedema, it was not necessary to preserve arm lymphatics. While the breast cancer patients who were performed mastectomy and ALND with 28 kg/m2 prepared to receive taxane-based chemotherapy, supraclavicular and infraclavicular radiotherapy, according to the established intraoperative nomogram, the proportion of the arm lymph flow above the axillary vein needed to exceed 52%. Otherwise, the arm lymphatics should be identified and preserved.
No_intervention: Standard axillary lymph node dissection
Standard axillary lymph node dissection was performed with complete resection of Berg's levels I and II.
Related Therapeutic Areas
Sponsors
Leads: Wuhan University

This content was sourced from clinicaltrials.gov