Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Procedure time for ESD
研究概览
简要总结
By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.
详细描述
Endoscopic submucosal dissection (ESD) has been accepted as an minimal invasive alternative to surgery for localized early upper gastrointestinal neoplasms recently. However, the procedure remains to be technically challenging and time consuming. Many modified methods or newly developed devices were developed to simplify the procedure. A new insulated tip dissecting knife (O-type Hybrid knife) has been recently developed with both injection and lateral cutting capability. The aim of this study was to investigate whether ESD procedure could be shortened with this new device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Gastric or esophageal adenoma or early cancer which is eligible for conventional ESD indications
- •The patients who agreed informed consent
排除标准
- •Recent drug history of anticoagulant or antiplatelet agent within 7 days
- •Recurrent gastric or esophageal adenoma or early cancer
- •Pregnant or breast feeding patients.
结局指标
主要结局
Procedure time for ESD
时间窗: up to 1 day
The time to finish the whole ESD procedure.
次要结局
- Submucosal dissection time(up to 1 day)
- Perforation rate(up to 7 day)
- Bleeding Rate(up to 7 days)
研究者
Zhiguo Liu
Associate Professor
Xijing Hospital of Digestive Diseases