跳至主要内容
临床试验/NCT02198729
NCT02198729已完成不适用

Endoscopic Submucosal Dissection Versus Endoscopic Mucosal Resection for Sessile Polyps and Laterally Spreading Lesions of the Rectum - a Prospective Randomised Trial

Professor Michael Bourke1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Recurrence

研究概览

简要总结

The investigators have recently become proficient in a new, and we believe more effective technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves removing the polyp in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. There have also been recent studies overseas that have shown this new technique to be quite effective. In this study, half of the patients will receive the newly developed technique of polyp removal (ESD), while the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment. This study will allow us to show which technique results in lower recurrence rates and is more effective.

详细描述

EMR is a very effective procedure for lesions smaller than 20 mm. With this size the polyp can be removed en bloc. En bloc resection is preferred as it minimises the likelihood of residual adenoma and enhances histological assessment. It is also curative in superficially invasive submucosal disease. It eliminates the need for surgery in these patients. With lesions larger than 20 mm, the lesion is removed piece meal, often in more than 5 pieces. Care is taken to ensure that no adenoma is left behind at the point of overlap between snare resections. However, for every additional snare resection, there is the possibility that a small amount of adenoma will be left behind at this overlap point. Overall, the literature suggests that there is approximately a 15% residual adenoma rate at repeat colonoscopy in 3 months, which requires further treatment. With en bloc resection residual adenoma rate at repeat colonoscopy in is close to 0%. This has to be balanced against the relative inexperience with performing ESD, longer procedure time and higher complication rates. A randomized trial near completion is comparing endoscopic snare resection with transanal surgical resection for rectal polyps (24). Should this trial show that en bloc resection is superior in achieving complete resection without recurrence at similar complication rates, the endoscopic treatment strategy of large colorectal adenomas should be reconsidered. Since en bloc resection is technically more challenging, this should have consequences for credentialing, referral patterns and performance of removal of large colorectal polyps in reference centers only. Thus, before en bloc resection is promoted as superior, and training has to be intensified to comply with standards of safe oncologic resection of these lesions, the efficacy and safety have to be proven in a comparative randomized trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Can give informed consent to trial participation
  • •Lesion size 20 mm to 50 mm
  • •Laterally spreading or sessile polyp morphology

排除标准

  • •Previous resection or attempted resection of target adenoma lesion
  • •Endoscopic appearance of invasive malignancy
  • •Age less than 18 years
  • •Pregnancy
  • •Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
  • •Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
  • •American Society of Anesthesiology (ASA) Grade IV-V

研究组 & 干预措施

Endoscopic Mucosal Resection

Active Comparator

Participants randomised to this arm will receive standard of care Endoscopic Mucosal Resection for removal of their lesions.

干预措施: Endoscopic Mucosal Resection (Procedure)

Endoscopic Submucosal Dissection

Experimental

Participants randomised to this arm will receive Endoscopic Mucosal Dissection to remove their lesion.

干预措施: Endoscopic Submucosal Dissection (Procedure)

结局指标

主要结局

Recurrence

时间窗: 18 months

Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations

次要结局

  • complication rates(14 days)
  • One piece resection rate(14 days)
  • Recurrence(up to 3 years)
  • Technical success of EMR(14 days)

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

Director of Gastrointestinal Endoscopy

Western Sydney Local Health District

研究点 (1)

Loading locations...

相似试验