A Phase II Trial of Esophageal and Gastric Stenting for Leak or Perforation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.
研究概览
简要总结
Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.
详细描述
This study is written to evaluate our experience treating esophageal fistulas with occlusive self-expanding covered metal stents. The long-term outcomes of patients treated with this new type of stent are as yet unknown. The differences between these stents is also unknown, as well as the ease of removal, efficacy, and/or placement. The intent of this study is not to determine which stent is better, but to merely evaluate the use of both. With this in mind, there will be no randomization of stent use, nor will there be restrictions on which stent may be used in which setting. This will be left to the judgment of the clinical placing the 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
- Treatment
- 盲法
- None
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
- •Patients must have radiographic or endoscopic proof of an esophageal leak or fistula.
- •Patients will be required to undergo imaging with CT scan, endoscopy, or fluoroscopy to investigate the leak. Once the location of the leak is identified, then patients must be taken for stenting and any adjunctive treatment within 12 hours of diagnosis or within 12 hours of arrival to The Methodist Hospital.
- •Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
排除标准
- •Patients who will not agree to return for routine follow-up and studies.
- •Patients who will not tolerate an endobronchial ultrasound or endoscopic procedure (coagulopathy [INR>1.8, PTT>60, or platelet level <50], hemodynamically unstable [MAP<50 or SBP<80], or other medical illness precluding safe endoscopy).
- •Patients who have a perforation too high to stent (such as the back of the pharynx, where a stent is not able to be placed), the only unfavorable anatomic location is this one listed above; we believe all other locations are amenable to stent placement.
- •Resectable carcinoma, megaesophagus, severe stricture, or caustic ingestion.
结局指标
主要结局
Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.
时间窗: 15 - 30 days
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Efficacy of esophageal stenting by the success of leakage stops and fistula healing.
时间窗: 15 - 30 days
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
A 30 day duration of stent placement and the relation to the healing esophagus
时间窗: 30 days
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. Evaluation of the healing process of the esophagus within first 30 days with the capability of its removal procedure. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
次要结局
- An institutional protocol for stent management(1 year)