Suturing Pattern for Endolumenal Stenting Procedures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Stent migration rate
研究概览
简要总结
Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.
详细描述
The participants who are receiving esophageal stent placement will be prospectively randomized to receive two suturing patterns (simple interrupted pattern and triangular pattern) for endoscopic esophageal stent fixation. We will investigate rate of the stent migration at 3-4 weeks by endoscopy after the stent placement as part of routine clinical care. Data of the duration of endoscopic suturing, adverse events, details of the stent used, indication for use will also be collected.
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
- •Subjects aged 18 or above
- •Subjects undergoing esophageal stent placement with any indication
排除标准
- •Imprisoned individuals,
- •Institutionalized patients
- •Inability or unwillingness of individual
结局指标
主要结局
Stent migration rate
时间窗: 4 weeks post stent placement
Number of participants with stent migration as assessed by objective evidence of stent migration on endoscopy at 3-4 weeks after esophageal stent placement
Adverse Events
时间窗: 4 weeks
Number of adverse events reported
次要结局
未报告次要终点
研究者
Barham K. Abu Dayyeh, M.D.
Principal Investigator
Mayo Clinic