NCT04056260Unknown不适用
Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer
Ho Seok Seo0 个研究点目标入组 219 人开始时间: 2020年3月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 219
- 主要终点
- sensitivity and specificity
研究概览
简要总结
As the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. Therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. However, adequate lymph node dissection is important as well. The aim of the study is to identify the feasibility of indocyanine green - near infra-red (ICG-NIR) guided sentinel lymph node dissection for the treatment of gastric cancer.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dignosed gastric adenocarcinoma
- •tumor: size 4cm or smaller
- •depth of invasion: mucosa, submucosa, proper muscle
- •candidates of laparoscopic radical gastrectomy
- •informed consent
排除标准
- •metachronous malignancy
- •number of tumors: 2 or more
- •remnant gastric cancer
- •indication for endoscopic resection
- •history of chemotherapy or radiation therapy
- •pregnancy
- •allergy to ICG
- •metastatic gastric cancer
结局指标
主要结局
sensitivity and specificity
时间窗: 1 month
sensitivity and specificity of ICG-NIR guided lymph node dissection
次要结局
未报告次要终点
研究者
Ho Seok Seo
professor
Seoul St. Mary's Hospital
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