NCT05502276已完成不适用
Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), "no Lift" Lesions and Residual / Relapses of Previous Resections. Endoscopic.
University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- En-bloc resection rate
研究概览
简要总结
Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm
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 of age >18 years
- •Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter
- •"no-lift" colic injuries ≤ 3cm in diameter
- •residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter
排除标准
- •pregnant women
- •failure to accept or understand the consent to participate in the study
- •patients with severe coagulopathies
- •patients with short life expectancy (Charlson comorbidity index ≥8)
- •patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)
结局指标
主要结局
En-bloc resection rate
时间窗: 1 year
the rate of one-piece resection of the lesions
R0 resection rate
时间窗: 1 year
percentage of patients with histologically negative lateral and deep margins
次要结局
未报告次要终点
研究者
Giulio Antonelli
Principal Investigator
University of Roma La Sapienza
研究点 (2)
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