Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
研究概览
简要总结
The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.
详细描述
All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo an axillary lymph node dissection
- •Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
- •English speaking
排除标准
- •Prior ipsilateral axillary lymph node dissection
- •Prior ipsilateral axillary radiation
- •Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
- •Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
- •Pregnant patients cannot participate in the substudy
研究组 & 干预措施
ALND with ARM +/- LVB
Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.
干预措施: ALND with ARM +/- LVB (Procedure)
ALND without ARM +/- LVB
Axillary Lymph Node Dissection (ALND)
干预措施: ALND (Procedure)
结局指标
主要结局
Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
时间窗: 36 months following surgery
Validated patient reported surveys
Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity
时间窗: 36 months following surgery
Bilateral Limb volume measurements
次要结局
未报告次要终点
研究者
James W. Jakub
Principal Investigator
Mayo Clinic