Comparison of Stent Suturing Versus OTSC Stentfix in Preventing Esophageal Stent Migration in Non-Stricture Esophageal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Average rate of stent migration
研究概览
简要总结
The purpose of this study is to investigate whether OTSC stentfix is a feasible, safe, and efficient device that can be used for esophageal stent fixation (to prevent stent migration) in patients with benign, non-stricture esophageal lesions, including leaks, perforation, and fistulae. Currently, self-expandable metal stents (SEMS) have a risk of migration which can lead to adverse events such as bleeding and perforation. There has been clinical experience demonstrating that stent suturing can prevent stent migration. However, stent suturing can significantly increase endoscopic procedural time. The use of OTSC stentfix for stent fixation is promising as it is likely less time-consuming and less technically difficult, with likely a similar rate of fixation and migration. This non-inferiority study aims to investigate how OTSC stentfix functions as compared to stent suturing. If OTSC stentfix is at least comparable to stent suturing, it can reduce endoscopy procedural times, minimize peri-endoscopic risks, and minimize adverse events related to stent migration.
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
- Single (Participant)
盲法说明
Patients will be blinded as to which study arm they are in, in order to avoid any bias they may have.
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
- •All adults (18+ years)
- •Have benign, non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
- •Ability to consent to stent fixation.
排除标准
- •< 18 years old
结局指标
主要结局
Average rate of stent migration
时间窗: 48 weeks
次要结局
- Procedural time needed for stent fixation(120 minutes)
- Duration of time until stent migration for stents that fail fixation(48 weeks)
