Fully, Coated, Removable, Self-expanding Oesophageal Stents for the Prevention of Oesophageal Stricture Following Endoscopic Mucosal Resection of Short Segment Barrett's With High Grade Dysplasia and Early Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Improvement in Stricture Formation
研究概览
简要总结
The purpose of this study is to investigate whether preventative placement of a removable oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks later by repeat Endoscopy. Patients will be followed up weekly following insertion of the oesophageal stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with short segment Barrett's Oesophagus with high grade dysplasia or early cancer, having circumferential EMR to achieve complete Barrett's excision.
- •Aged 18-75 years old
- •Biopsy proven to be Barretts with HGD or EAC
- •The absence or lymph node involvement
- •Short segment <3cm of Barretts Oesophagus.
排除标准
- •Women who are pregnant and the human foetus
- •Children and/or young people <18 years
- •People with an intellectual or mental impairment.
结局指标
主要结局
Improvement in Stricture Formation
时间窗: 12 weeks
Initial evaluation of Dysphagia score which is used to assess the stricture formation prior to EMR. Followed by weekly phone calls to assess ability to swallow liquids and food.
次要结局
未报告次要终点
研究者
Professor Michael Bourke
Dr Michael Bourke
Western Sydney Local Health District