Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Success of resection
研究概览
简要总结
Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique.
Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas.
In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).
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
- •patients ≥ 18 years
- •adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign")
排除标准
- •patients < 18 years
- •lesions > 20 mm in size
- •high risk carcinomas ("deep submucosal carcinoma")
- •American Society of Anesthesiologists (ASA) class IV and higher
结局指标
主要结局
Success of resection
时间窗: 3 month
Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment
次要结局
- Duration of procedure(up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day))
研究者
Dr. Peter Klare
Dr. med. Peter Klare
Technical University of Munich