A Phase Ⅲ, Multicenter, Prospective, Open-Label, Controlled Study of Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema in Breast Cancer Patients Following Axillary Lymph Node Dissection and Adjuvant Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Lymphedema incidence
研究概览
简要总结
Breast cancer-related lymphedema (BCRL) is one of the most common chronic complications following breast cancer treatment. This study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. Based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (ID-LVA) following axillary lymph node dissection (experimental group) or not (control group). The study aims to evaluate the safety and efficacy of ID-LVA in preventing breast cancer-related upper limb lymphedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >=18 years;
- •Pathologically confirmed invasive breast cancer;
- •Unilateral breast cancer;
- •Clinical stage T1-4 and N1-3 (post-neoadjuvant therapy staging for patients receiving neoadjuvant treatment);
- •No clinical or radiographic evidence of distant metastasis;
- •Scheduled to undergo axillary lymph node dissection with planned adjuvant radiotherapy;
- •Willing and able to provide written informed consent.
排除标准
- •Currently participating in other clinical trials that, in the investigator's judgment, may affect upper limb lymphatic drainage.
- •No definitive indication for axillary lymph node dissection or adjuvant radiotherapy after neoadjuvant therapy.
- •Pregnant or lactating women.
- •Patients undergoing concurrent autologous tissue flap breast reconstruction or chest wall repair.
- •Upper limb deformities, prior upper limb trauma, or surgical history that, in the investigator's assessment, may compromise lymphatic drainage.
- •Pre-existing upper limb lymphedema at baseline.
研究组 & 干预措施
ID-LVA Group
Immediate distal lymphaticovenous anastomosis (ID-LVA) performed concomitantly with axillary lymph node dissection (ALND)
干预措施: Immediate Distal Lymphaticovenous Anastomosis (ID-LVA) (Procedure)
non-ID-LVA Group
Axillary lymph node dissection (ALND) without concurrent immediate distal lymphaticovenous anastomosis (ID-LVA)
结局指标
主要结局
Lymphedema incidence
时间窗: From enrollment to 24 months after surgery
Breast cancer-related lymphedema (BCRL) was assessed using relative volume change (RVC) derived from circumferential measurements of both upper limbs. Certified lymphedema therapists performed standardized measurements at anatomical landmarks: the web space, ulnar styloid midpoint, and points 10, 20, 30, and 40 cm above the ulnar styloid; axillary measurements were added if needed. Segmental volumes were calculated using the truncated cone formula: V = (πh/12) × (C₁² + C₁C₂ + C₂²), where h = 10 cm, and C₁, C₂ are circumferences at segment ends. Total arm volume was the sum of all segments. RVC was computed as: RVC = (A₂U₁) / (A₁U₂) × 100%, where A₁/A₂ = pre-/postoperative volume of the affected arm, and U₁/U₂ = pre-/postoperative volume of the unaffected arm. If weight fluctuated significantly, weight-adjusted change (WAC) was calculated: WAC = (A₂ × W₁) / (W₂ × A₁) - 1, where W₁ and W₂ represent the preoperative and postoperative body weight.
次要结局
- Lymphedema Severity(From enrollment to 24 months after surgery)
- Lymphedema-Associated Symptoms(From enrollment to 24 months after surgery)
- Quality of Life (QoL)(From enrollment to 24 months after surgery)
- Surgery-Related Complications(From the day of surgery to 1 month after surgery)
- Radiation-Related Complications(From the day of radiation to 7 days after radiation)
- Disease-Free Survival (DFS)(From enrollment to 24 months after surgery)
- Local Recurrence-Free Survival (LRFS)(From enrollment to 24 months after surgery)
- Overall Survival (OS)(From enrollment to 24 months after surgery)