The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Long term outcomes: recurrent and residual disease
研究概览
简要总结
To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions
详细描述
To collect prospective observational data on patients undergoing ESD, EFTR or STER for UGI neoplastic lesions
- Lesion characteristics including histology
- Procedural outcomes
- Safety Outcomes
- Efficacy outcomes
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
- •UGI neoplastic lesions > 10mm
- •Lesions for ESD limited to the mucosal and/or submucosal layer OR
- •Lesions for EFTR limited to the muscularis propria layer OR
- •Lesions for STER limited to the submucosal and/or muscularis propria layer
- •Aged 18 years or older
排除标准
- •Age less than 18
- •Unable to give informed consent
- •Pregnant or lactating patients
- •Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally
结局指标
主要结局
Long term outcomes: recurrent and residual disease
时间窗: 3 years
Determined at subsequent procedures
Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection
时间窗: 2 weeks
Determined based on clear margins in histology review
Safety: intra and post procedural; bleeding; perforation; anaesthetic
时间窗: 30 day
Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
次要结局
- Patient interviews/questionnaires(3 years)
- Need for surgery(2 months)
- Post ESD, EFTR, STER defect features(1 day)
- Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives(6 months)
- Need for more than one endoscopic therapy(3 years)
研究者
Professor Michael Bourke
Director of Endoscopy
Western Sydney Local Health District