Endoscopic Full Thickness Resection Without Exposure to Peritoneum: Single Center Single Arm Study
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- En bloc resection
研究概览
简要总结
This study evaluates the feasibility of endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) in patients with gastric tumor.
详细描述
Current endoscopic full-thickness resection (EFTR) methods are limited by their transmural communication and exposure of tumor to peritoneum. Recently, endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) was developed. This new technique includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.
This study evaluates the feasibility of simple non-exposure EFTR technique in patients with gastric tumor. This study is single arm study and will be performed in single center.
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
- •Tumor invades of muscularis propria on endoscopic ultrasonography (EUS) finding
- •Tumor size more than 1.5cm or increasing size during observation
排除标准
- •Tumor size more than 5cm
- •Refuse to be enrolled to study.
- •Bleeding tendency,
- •Inappropriate condition for surgery with general anesthesia
结局指标
主要结局
En bloc resection
时间窗: During operation
rate of en bloc resection (%)
次要结局
- procedure time(During operation)
- successful closure of resection site(1 week)
- complication(3 months)
研究者
Chan Gyoo Kim
Senior Scientist
National Cancer Center, Korea