Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Volumetric diagnosis of lymphedema
研究概览
简要总结
This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.
SECONDARY OBJECTIVES:
I. Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.
OUTLINE: Patients are randomized to 1 of 2 groups.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients greater than or equal to 18 years of age.
- •Patients willing to participate.
- •Patients able to complete informed consent.
- •Patients will be eligible for inclusion if they fall into one for two groups:
- •Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy
- •Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group.
排除标准
- •Patients taking anticoagulants within 7 days prior to surgery.
- •Patients that are known to be pregnant at the time of surgery.
- •Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
- •Patients with body mass index (BMI) greater than 50.0.
研究组 & 干预措施
Group I (LVB)
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
干预措施: Lymphangiography (Procedure)
Group I (LVB)
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
干预措施: Lymphovenous Bypass (Procedure)
Group I (LVB)
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Volumetric diagnosis of lymphedema
时间窗: 18 months
If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.
Incidence of lymphedema
时间窗: 18 months
Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
次要结局
未报告次要终点