NCT06076382Unknown不适用
A Prospective Randomized Controlled Study Protocol Between Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery
Jilin University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年3月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- operating time
研究概览
简要总结
A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery
详细描述
This study compare and analyze the efficiency of endoscopic ultrasound guided colorectal ESD surgery with traditional colorectal ESD surgery, in order to guide colorectal ESD operations.
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
- 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
- •Cases in our hospital who require colorectal ESD surgery
- •Colorectal lesions（laterally spreading tumor）.
排除标准
- •Laterally spreading tumor but not nodular mixed type(LST-G-M)
- •Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;
结局指标
主要结局
operating time
时间窗: During surgery
from the injection to the end of dissection （minutes）
Measure the area of the lesion
时间窗: During surgery
Measure the length and diameter of the lesion
次要结局
- Number of propria muscle layer injuries during surgery(During surgery)
- Time to first fluid diet(one week after surgery)
- Complete resection rate(1 year)
研究者
Dong Yang
Assisted Investigator
Jilin University
研究点 (2)
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