Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- R0 Resection
研究概览
简要总结
Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip [OTSC] clips).
详细描述
During an initial pilot phase 8 patients receive endoscopic resection under laparoscopic control. Thereafter and after positive initial results sole endoluminal endoscopy is done for a total of 38 patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endosonographically suspicous gastric subepithelial mass <=3 cm.
排除标准
- •American Society of Anesthesiologists (ASA) classes IV or V
- •Pregnancy
- •Bleeding disorders
- •Contraindications for endoscopy
- •Endosonographically shown large vessels in the area for resection
结局指标
主要结局
R0 Resection
时间窗: 30 minutes
Rate of R0 resections by an endoscopic approach for resection.
次要结局
- Safety(30 minutes)