Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The total number of detection rate of (positive) lymph nodes using ICG
研究概览
简要总结
The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG).
详细描述
ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected into the tumor or directly surrounding tissue.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally limited prostate cancer;
- •Intermediate or high risk tumor
- •Recommended and planned prostatectomy;
- •Completed and signed written consent;
- •Voluntarily agreement to participate in this study
- •Age of the study participants ≥ 18 years.
排除标准
- •Allergic reaction to active ingredient (indocyanine green);
- •Iodine allergy;
- •Hyperthyroidism;
- •High-grade renal impairment;
- •High-grade hepatic insufficiency;
- •Unwillingness to the storage and disclosure of pseudonymous disease and personal data
- •psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question
研究组 & 干预措施
Lymphadenectomy using standard Methods
Lymphadenectomy will be performed as a standard procedure
Lymphadenectomy using ICG
A fluorescent dye (indocyanine green) will be ultrasound-controlled preoperatively injected in the prostate. During robot-assisted radical intervention by DaVinci ® robot the lymphadenectomy is performed using the fluorescence lymphography.
干预措施: ICG (Procedure)
结局指标
主要结局
The total number of detection rate of (positive) lymph nodes using ICG
时间窗: during the surgery
次要结局
- Measurements of the time, that takes to remove the lymph nodes(During the surgery)