Comparison of Coventional Endoscopic Submucosal Dissection and Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- procedure time
研究概览
简要总结
This study is aimed to analyze the outcomes after conventional endoscopic submucosal dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is more than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without stalk.
Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in diameter with snaring, then resected by using an electric current.
The investigators expect optimized ESD with snaring can provide more time-saving procedure with comparable en-bloc resection rate and perforation rate, when compared with the conventional ESD method.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •colorectal laterally spreading tumor that is more than 20 mm in diameter
- •other elevated or flat colorectal neoplasm without stalk, that is more than 20 mm in diameter
排除标准
- •colorectal neoplasms that are proven or suspected to be invaded more than submucosal invasion
- •colorectal neoplasms that have severe fibrosis beneath the target lesion
- •patient's refusal to participate this study
- •less than 18 years old
- •subjects who cannot consent voluntarily due to the communication difficulty
结局指标
主要结局
procedure time
时间窗: 8 months
En Bloc resection rate
时间窗: 8 months
次要结局
- histologic complete resection rate(8 months)
- complication rate(8 months)
研究者
Jeong-Sik Byeon
Asan Medical Center
Asan Medical Center