NCT03039309招募中不适用
Endoscopic Submucosal Dissection in the Treatment of Early Gastrointestinal Neoplasia: A UK Cohort Study to Assess Effectiveness and Safety
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Curative resection rate
研究概览
简要总结
Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.
详细描述
Data will be collected from participating centres on en bloc resection, curative resection, R0 resection and complications/adverse events over a 2 year follow up period.
Demographic details on the patients included in the study will be captured alongside details on the size and location of their early gastrointestinal dysplastic/neoplastic lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection
- •Participant is able to give informed consent for participation in the study
排除标准
- •Patients under the age of 18
- •Patients unable to give informed consent
结局指标
主要结局
Curative resection rate
时间窗: 2 years
% of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)
次要结局
- Mortality rates(2 years)
- En bloc resection rate(At the time of procedure)
- Complication rates(28 days post procedure)
研究者
研究点 (2)
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