Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
研究概览
简要总结
This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.
详细描述
Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Duodenal and ampullary lesion > 10mm
- •Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
- •Aged 18 years or older
排除标准
- •Lesion less than 10mm
- •Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
- •Aged younger than 18 years
结局指标
主要结局
Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
时间窗: 14 days
次要结局
- Analysis of the costs of this procedure compared to previous treatments(14 days)
研究者
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District