The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Resection speed (mm2/min)
研究概览
简要总结
Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.
详细描述
Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD. Location, morphology and size of the lesion will be recorded. Time of the procedure will be measured using a stopwatch
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a lesion in the colon or rectum suitable for removal by the ESD technique
排除标准
- •inability to understand the written study information
研究组 & 干预措施
Standard
Standard endoscopic submucosal dissection
Interventional
Mandatory use of the clip-traction device
干预措施: clip-traction (Device)
结局指标
主要结局
Resection speed (mm2/min)
时间窗: Within completion of procedure
Measured as area of the removed lesion divided by procedure time.
次要结局
未报告次要终点
研究者
Richard Marsk
Principal investigator
Karolinska Institutet