Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Incidence of lymphedema
研究概览
简要总结
Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.
详细描述
Patients in the LYMPHA group undergo Axillary reverse mapping before the start of surgery, and after axillary lymph node resection, LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 19 years old
- •Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery.
排除标准
- •Patients with vascular and lymph-related diseases
- •Patients with a history of surgical treatment or trauma to both arms and axillary
- •Patients with a history of receiving radiation treatment in both arms, chest, and axilla
- •Patients with confirmed systemic metastasis with stage 4 breast cancer
- •Pregnant and lactating patients
结局指标
主要结局
Incidence of lymphedema
时间窗: 2 years after surgery
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.
次要结局
- Changes in Lymphoscintigraphy(2 years after surgery)
- 5-year overall survival rate(5 years after surgery)
- UEL index(2 years after surgery)
- Incidence of lymphedema(5 years after surgery)
- 5-year recurrence rate(5 years after surgery)
研究者
Joon Jeong
Professor
Gangnam Severance Hospital