Efficacy and Safety of Underwater Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection for the Treatment of Large Non-pedunculated Colonic Lesions. Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 356
- 试验地点
- 4
- 主要终点
- Lesion recurrence rate
研究概览
简要总结
To analyse the efficacy and safety of two standard methods of endoscopic mucosal resection (EMR) for large non-pedunculated colorectal polyps, the investigators will compare submucosal injection-assisted endoscopic mucosal resection (SEMR) versus underwater endoscopic mucosal resection, without submucosal injection (UEMR).
详细描述
Underwater endoscopic mucosal resection (UEMR) emerges as a variant of traditional resection, in which a submucosal cushion formation is not necessary. This technique was described in 2012 by Kenneth Binmoeller based on the physical floating effect of colonic mucous membrane by filling the colonic lumen using water instead of air. This "floating effect" conditions the natural separation of the colonic wall layers, allowing the distension of the submucosal space without the need to inject substances into it. On the other hand, performing resection in liquid medium conditions could drive the benefit of heat dissipation caused by the current, which would reduces thermal damage caused to the tissues.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients aged >18 years, diagnosed with a large (>=20 mm) non-pedunculated colonic polyp, who consent to endoscopic mucosal resection of the polyp and willing to participate in this study.
排除标准
- •Polyps showing signs of deep submucosal invasion
- •Inflamatory bowel disease with signs of activity
- •Known or suspected pregnancy
- •Patients unable or unwilling to provide informed consent
研究组 & 干预措施
Underwater EMR
The patients randomized in this arm will be treated by endoscopic resection assisted by the filling of the colonic lumen using water instead of air and avoiding the formation of a submucosal cushion
干预措施: Underwater EMR (Procedure)
Conventional EMR
The patients randomized in this arm will be treated by endoscopic resection following the traditional technique. It means, by assistance of selective submucosal saline injection to create a submucosal cushion below the polyp.
干预措施: Conventional EMR (Procedure)
结局指标
主要结局
Lesion recurrence rate
时间窗: 1 year
Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)
次要结局
- Technical success rate(1 hour)
- Incidence of Treatment-Emergent Adverse Events(1 year)
- En bloc Resection rate(1 hour)
- Procedure time(1 hour)
- Number of fragments(1 hour)
- Lesion size(1 hour)
- Thermal artecfacts(1 hour)