跳至主要内容
临床试验/NCT01369316
NCT01369316撤回不适用

Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Resection for the Removal of Large Laterally Spreading Tumours and Sessile Polyps of the Colon

Professor Michael Bourke2 个研究点 分布在 1 个国家开始时间: 2020年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)

研究概览

简要总结

That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon.

详细描述

The investigators have recently developed a new, and the investigators believe safer and more effective technique for endoscopic mucosal resection (EMR). Utilising the new method the investigators make small cuts around the polyp to isolate it. Subsequently the Gelofusine solution is injected beneath the polyp and provides greater elevation. This allows us to improve the chance of removal of the entire polyp with one attempt in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. Our team has recently completed an animal study comparing our newly developed technique to conventional EMR. The investigators have found significant improvements in our ability to completely remove the polyp in one attempt. There have also been recent studies overseas that have shown this new technique to be quite effective.

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 (Investigator)

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

入选标准

  • Can give informed consent to trial participation
  • Age greater than 18
  • Adenomas that have not have previously been attempted for resection (i.e. naïve lesions)
  • Adenoma size greater than 20 mm

排除标准

  • Age less than 18
  • Previous resection or attempted resection of target adenoma lesion
  • Pregnant patients

结局指标

主要结局

Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Professor Michael Bourke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Professor Michael Bourke

Dr Michael Bourke

Western Sydney Local Health District

研究点 (2)

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