Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Freedom from lymphedema (FFL)
研究概览
简要总结
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
详细描述
Primary Objectives
- To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in participants with a diagnosis of IBC undergoing ILR at the time of ALND.
Secondary Objectives
- Estimate the proportion of participants who have lymphedema that persists at 2 years after ILR surgeries.
- Determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ILR.
- Evaluate changes in systemic inflammatory mediators and systemic immune cell function affiliated with lymphedema development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with IBC.
- •Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
- •Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
- •Female subjects at least 18 years old and capable of providing consent to participate.
- •Females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study.
排除标准
- •Patients known to be pregnant or breast-feeding.
- •Patients with known or suspected iodine or ICG hypersensitivity.
- •Patients unable to remain stationary for one hour.
- •Active cellulitis.
- •Subjects with a preoperative clinical lymphedema diagnosis.
- •Subjects undergoing bilateral ALND.
- •Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
- •Patients with BMI >45kg/m2.
研究组 & 干预措施
Postoperative Evaluations
Participants who agree to take part in this study, clinic visit timing will be exactly the same time as would ordinarily be scheduled: before surgery, then 6, 12, 18, and 24 months after surgery. Each study visit should take about 2-3 hours.
干预措施: Immediate Lymphatic Reconstruction (ILR)/ (Procedure)
Postoperative Evaluations
Participants who agree to take part in this study, clinic visit timing will be exactly the same time as would ordinarily be scheduled: before surgery, then 6, 12, 18, and 24 months after surgery. Each study visit should take about 2-3 hours.
干预措施: Prophylactic Lymphovenous Bypass (pLVB) (Procedure)
结局指标
主要结局
Freedom from lymphedema (FFL)
时间窗: 2 years
次要结局
未报告次要终点