The Feasibility and Efficacy of ICG-coated Endoscopic Clip for Tumor Localization in Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Success rate of localization
研究概览
简要总结
The fluorescent clipping method involves endoscopic clipping a fluorescent clip into the colonic lesion site in advance of surgery, and observing the position of the fluorescence through the colonic wall by a light source of a certain wavelength band during surgery.
The purpose of this study is to evaluate the efficacy of the localization of colonic lesions using ICG coated endoscopic clip in laparoscopic colon surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases which are deemed necessary to mark the location of the colon lesion before surgery
排除标准
- •Preoperative colonoscopy is not possible due to intestinal obstruction
- •If the lesion is located in the rectal area and the lesion can be confirmed by digital rectal exam
- •disagreement with the study
研究组 & 干预措施
ICG clip
Three clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery
干预措施: ICG-coated clip (Device)
结局指标
主要结局
Success rate of localization
时间窗: through study completion, an average of 1 year
The rate of Identifying ICG-coated clip during surgery
次要结局
- Number of Participants with Complication(through study completion, an average of 1 year)
- loss rate of clips(through study completion, an average of 1 year)
研究者
Dae Kyung Sohn
Principal Investigator
National Cancer Center, Korea