NCT04198337招募中不适用
Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Complete resection of GIST
研究概览
简要总结
This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST
详细描述
To evaluate the clinical safety and efficacy of endoscopic full thickness resection (EFTR) for treatment of gastric GIST. A total of 30 patients will be recruited
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and ≤ 80
- •Gastric submucosal tumors located at cardia, lesser curvature and antrum
- •Size of the submucosal tumor between 10mm to 30mm as assessed by endoscopic
排除标准
- •Patients who are considered as unfit for general anesthesia
- •ASA class ≥ IV or moribund patients
- •Gastric submucosal tumors located at greater curvature and fundus
结局指标
主要结局
Complete resection of GIST
时间窗: 30 days
Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins
次要结局
- Hospital stay(30 days)
- Perioperative mortality(30 days)
- Adverse event rate(30 days)
- Histolology assessment(30 days)
- technical success in complete resection(1 day)
研究者
Philip Wai Yan CHIU
Professor
Chinese University of Hong Kong
研究点 (2)
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