Identifying and preserving arm lymphatics in breast cancer patients
Identification and Preservation of Arm Lymphatics (DEPART) in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Multicenter Randomized Clinical Trial
This study is testing a new technique to help breast cancer patients keep their arm lymphatic system intact during surgery to see if it can reduce swelling in the arm afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Wuhan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04446494 on ClinicalTrials.gov |
What this trial studies
This study investigates the DEPART technique, which aims to identify and preserve the arm lymphatic system during axillary lymph node dissection in patients with breast cancer. By using indocyanine green and methylene blue to locate arm sentinel nodes, the study seeks to reduce the incidence of arm lymphedema following surgery. The research will track rates of arm lymphedema, locoregional recurrence, and the feasibility of the DEPART technique through various follow-up examinations. The goal is to enhance surgical outcomes and minimize complications associated with breast cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 or older with T1-3 invasive breast cancer who are clinically node-positive and undergoing mastectomy or breast-conserving surgery.
Not a fit: Patients who have received neoadjuvant chemotherapy or have a previous history of breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of arm lymphedema in breast cancer patients undergoing surgery.
How similar studies have performed: While the DEPART technique is a novel approach, similar studies focusing on lymphatic preservation have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Qianqian Yuan, MD.
- Email: Yuanqq11@whu.edu.cn
- Phone: +8613026322297
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.