Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence rate of lymphedema development
研究概览
简要总结
This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.
详细描述
PRIMARY OBJECTIVE:
I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction.
SECONDARY OBJECTIVES:
I. Determine the overall complications of prophylactic vascularized lymph node transfers.
II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction
排除标准
- •Patients that are known to be pregnant at the time of surgery
- •Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)
研究组 & 干预措施
Treatment (vascularized lymph node transfer)
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
干预措施: Mammoplasty (Procedure)
Treatment (vascularized lymph node transfer)
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
干预措施: Vascularized Lymph Node Transfer (Procedure)
结局指标
主要结局
Incidence rate of lymphedema development
时间窗: At 12 months after surgery
Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated.
Time to lymphedema development
时间窗: Up to 2 years
Will be estimated by the Kaplan-Meier method.
次要结局
- Incidence rate of lymphedema development(Up to 2 years)
- Complications of prophylactic VLNT(Within 30 days after surgery)