Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The imaging effect of indocyanine green
研究概览
简要总结
Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy
详细描述
To observe the imaging result of endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy, and analyze the relevant factors, so as to guide the operation of preoperative indocyanine green submucosal injection better.
This study is prospective and observational. In order to analyze the related factors that affect the imaging effect, we enrolled patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy.
排除标准
- •have simultaneously other cancer
- •have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
- •have upper gastrointestinal surgery
- •Indocyanine green or iodine allergy
- •the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy
结局指标
主要结局
The imaging effect of indocyanine green
时间窗: During the operation
The imaging effect was evaluated by indocyanine green fluorescence imaging system during the operation. The effect was divided into grade0 and Grade1. Grade1: The imaging of the tumor and the corresponding lymphatic drainage area in the injection area both were ideal. Grade 0: not up to grade 1, classified into tumor body and drainage area without imaging, only tumor body imaging, and even though tumor body and regional lymph drainage area imaging, the contrast agent in the gastric wall was too diffuse or even overflowing, which seriously interfered with the observation of lymph drainage area imaging.
次要结局
未报告次要终点
研究者
Dong Yang
Doctor
Jilin University