The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration- Randomized Controlled Trial- A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 主要终点
- Esophageal SEMS migration rate at 4 weeks follow up.
研究概览
简要总结
New endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Therefore, some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration.
详细描述
Participants requiring esophageal SEMS placement for various indications such as stricture (benign, malignant), leaks All participants who require esophageal SEMS placement. Esophago-gastroscopy will be done to assess the feasibility of SEMS placement.
Participants are randomized into two arms- one arm (interventional) use of OTSC stent fix after esophageal SEMS placement or the other arm (non-interventional) esophageal SEMS is placed.
Participants are followed up for 1 year to observe stent migration rate in both the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults (18+ years)
- •Have benign, malignant 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
- •Patients aged under 18 years of age
- •Unable to provide informed consent
- •Inherited or acquired coagulopathy likely to affect the risk of bleeding
- •Receiving anticoagulant therapy that could not be stopped or bridged prior to procedure
- •Breast feeding, pregnant and lactating women's.
结局指标
主要结局
Esophageal SEMS migration rate at 4 weeks follow up.
时间窗: 4 weeks
Proportion of patients experiencing stent migration at 4 weeks after index procedure.
次要结局
- Migration of stent in both groups(6 months)
- Adverse events in both groups apart from stent migration(6 months)
- Improvement in dysphagia score(1 week)
- Procedural time in minutes(immediately after procedure)