Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Adenoma recurrence rate (ARR)
研究概览
简要总结
Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading adenomas
详细描述
Rationale:
Conventional EMR is well-established for the resection of lateral-spreading adenomas and has been shown to be highly efficacious with adjuvant STSC. Cauterisation-related complications occur relatively frequently and while endoscopically treatable, still carry morbidity not seen in current cold snare polypectomy data.
Cold snare polypectomy has an excellent safety profile for smaller polyps, without cauterisation-related adverse events. Limited data on cold EMR for large adenomatous laterally-spreading lesions shows minimal complications. Efficacy, however, is yet to be evaluated in prospective randomised trials. Observational data demonstrates recurrence rates exceeding conventional EMR. Since STSC causes significant reduction in recurrence in conventional EMR, the safety and efficacy of this adjuvant technique, when compared to isolated cold snare EMR, has theoretical advantages in both safety and efficacy.
The safety and efficacy of these two techniques will therefore be compared in a randomised controlled trial.
Hypothesis:
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)
盲法说明
Blinding
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient undergoing colonoscopy who is older than 18 years of age, has a written consent for trial participation and has at least one laterally spreading lesion meeting the following description:
- •Localisation in the colon or rectum
- •Benign adenomatous surface features (Kudo III / IV, Japan NBI Expert Team (JNET) 2a)
- •Granular or non-granular topography
- •Paris classification 0-IIa/IIb +/- Is
- •If present, sessile component may be no greater than 10mm in size.
- •Polyp size ranging from 15 to 40mm
排除标准
- •Current use of antiplatelet (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines.
- •Known bleeding disorder or coagulopathy.
- •Pregnancy
- •History of inflammatory bowel disease
- •Previously attempted or otherwise non-lifting lesions
- •Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3) or concurrent colorectal cancer
- •Lesions involving the ileocaecal valve (ICV), appendiceal oriface or anorectal junction (ARJ)
结局指标
主要结局
Adenoma recurrence rate (ARR)
时间窗: 4-6 months
ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)
Complete resection rate (CRR)
时间窗: 1 day
Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)
次要结局
- Intra-procedural and post-procedural complication rates(30 days)
研究者
Professor Michael Bourke
Professor
Western Sydney Local Health District