Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The lesion result before ESD
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.
详细描述
Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. In addition, in most patients, pathological assessment cannot be conducted after the procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform ESD for GI neoplasms because of the high rate of complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Submucosal tumor
- •Mucosal tumor (T1) in patients unsuitable for surgery
排除标准
- •Endoscopic ultrasound (EUS) or CT signs of metastasis
- •Insufficient access to tumor
结局指标
主要结局
The lesion result before ESD
时间窗: within 7 days before ESD
Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Short-term result after ESD
时间窗: whithin 7 days after ESD
Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion.
次要结局
- The safety of ESD procedure(3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD)