Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Drain output <100 mL
研究概览
简要总结
Goal is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy.
详细描述
The goal of this clinical trial is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy. The main question is if it could improve patients' quality of life and infection risk post-surgery. It would also help to decrease emergency room visits as well as additional procedures. Researchers will compare those who receive the ICG and those who do not.
Patients will be randomized into the ICG arm versus no ICG arm after pelvic lymphadenectomy is done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The investigator and participant will not know which arm the patient is randomized into while undergoing the surgery. It isn't until the surgery is complete that the patient will be randomized into either ICG injection versus not.
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing robotic assisted laparoscopic lymph node dissection
排除标准
- •Patient not undergoing extended lymph node dissection
- •History of allergy to iodides
研究组 & 干预措施
ICG Injection
This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.
干预措施: ICG injection (Drug)
ICG Injection
This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.
干预措施: Prostatectomy with pelvic lymph node dissection (Procedure)
ICG non-injection
This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.
干预措施: Non-Injection/Control (Other)
ICG non-injection
This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.
干预措施: Prostatectomy with pelvic lymph node dissection (Procedure)
结局指标
主要结局
Drain output <100 mL
时间窗: 2 weeks
A sample of 12 recent patients receiving the current standard procedure had a mean drain volume for the first 24 hours of 218 mL and standard deviation of 102. With a hoped-for reduction to \<100 mL/ 24 hr mean in the treatment arm, there would be 99% power to detect a difference, and 80% power to detect a difference of 57 mL between treatment and control arms. Given the small sample used for this power estimate, we believe that it is appropriate to power for a range of potential standard deviations and potential differences.
次要结局
- Lymphocele formation(4 weeks)