Multicenter, Randomised Controlled Trial Comparing Endoscopic Mucosal Resection (EMR) And Endoscopic Submucosal dissecTIon (ESD) for Resection of Large Distal Non-pedunculated Colorectal Adenomas (MATILDA-trial)
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Recurrence rate at follow-up colonoscopy after 6 months
研究概览
简要总结
Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. In large lesions, EMR can often only be performed in a piecemeal fashion resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this into perspective against the costs and complication rates of both strategies and the burden perceived by patients on the long term-term.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-pedunculated polyp larger than 20 mm in the rectum, sigmoid or descending colon found during colonoscopy
- •indication for endoscopic treatment
- •≥18 years old
- •Written informed consent
排除标准
- •suspicion of malignancy, as determined by endoscopic findings (invasive Kudo pit pattern, Hiroshima type C) or proven malignancy at histology
- •prior endoscopic resection attempt
- •presence of synchronous distal advanced carcinoma that requires surgical resection
- •the risk exceeds the benefit of endoscopic treatment, such as patient's with an extremely poor general condition or a very short life expectancy
- •the inability to provide informed consent
研究组 & 干预措施
EMR
In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.
干预措施: EMR (Procedure)
ESD
In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique.
干预措施: ESD (Procedure)
结局指标
主要结局
Recurrence rate at follow-up colonoscopy after 6 months
时间窗: 6 months
Observed from resected residual disease or, if not present, from biopsies of the scar
次要结局
- Long-term recurrence rate at follow-up colonoscopy after 36 months(36 months)
- Health care resource utilization and consts(36 months)
- Perceived burden and quality of life among patients(36 months)
- Complication rate(30 days)
- Surgical referral rate(36 months)
- R0-resection rate(30 days)
研究者
L.M.G. Moons
dr. L.M.G. Moons, Principal Investigator
UMC Utrecht