Endoscopic Full Thickness Resection With Laparoscopic Assistance, Single Center Single Arm Study
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- En-bloc resection and successful closure
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance.
详细描述
The laparoscopic resection with a linear stapler for subepithelial tumors (SET) can lead to excessive resection of healthy tissue of the gastric wall resulting in deformity or stenosis. Attaining a positive surgical margin is also possible. Endoscopic full-thickness resection (EFTR) can be used for tumor resection by direct visualization of the tumor from inside the stomach lumen leading to a free surgical margin with little resection of healthy tissue. In order to overcome current endoscopic technical limitations, we will combine the conventional laparoscopic approach with EFTR.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric subepithelial tumor
- •Invasion of muscularis propria on Endoscopic ultrasound
- •Tumor size 1.5cm-5cm or increasing size during follow-up
排除标准
- •Bleeding tendency,
- •Inappropriate condition for surgery with general anesthesia
- •Refuse to be enrolled to study
结局指标
主要结局
En-bloc resection and successful closure
时间窗: 3 months after surgery
successful En-bloc resection of subepithelial tumor and successful closure of resection site by Endoscopic full-thickness resection with laparoscopic assistance.
次要结局
- number of troche(during surgery)
研究者
Chan Gyoo Kim
Senior Scientist
National Cancer Center, Korea