NCT01699542已完成不适用
A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Esophageal Strictures
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Number of Dilation Procedures
研究概览
简要总结
The purpose of this of this study is to compare the safety and effectiveness of temporary indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of refractory anastomotic esophageal strictures
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
- 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
- 是
入选标准
- •Esophageal anastomotic stricture post esophagectomy (esophagogastric strictures).
- •Esophagectomy performed at the same institution where patient enrollment and follow-up is planned.
- •Two dilations to at least 16 mm in diameter since esophagectomy.
- •1st dilation no more than 6 months post esophagectomy and 2nd dilation within 6 months of 1st dilation to 16mm.
- •Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
- •Unable to pass a standard endoscope (approx. 9.8 mm diameter).
- •Age 18 years or older.
- •Willing and able to comply with the study procedures and provide
排除标准
- •Stricture within 2 cm of the upper esophageal sphincter.
- •Dysphagia related to motility disorder.
- •Non-anastomotic esophageal strictures.
- •Esophagocolonic strictures.
- •Planned adjuvant radiation therapy post esophagectomy.
- •Prior esophageal stent placements post esophagectomy.
- •Active erosive esophagitis.
- •Sensitivity to any components of the stent or delivery system.
- •Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
- •Stricture length > 5 cm.
研究组 & 干预措施
Metal Stent
Active Comparator
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
干预措施: WallFlex Esophageal RX Fully Covered Stent (Device)
Bougie Dilation
Active Comparator
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
干预措施: Esophageal Bougie Dilator Per Investigator preference (Device)
结局指标
主要结局
Number of Dilation Procedures
时间窗: 12 months
Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
次要结局
- Number of Participants With Technical Stent Removal Success(12 months)
- Number of Participants With Technical Stent Placement Success(12 months)
- Patient's Satisfaction With the Therapy(Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12)
- Patient's Report of Pain(Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12)
- Quality Of Life Overall Health Score(Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12)
- Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure(12 months)
- Time to Recurrence of Dysphagia(12 months)
- Total Number of Stent Migrations(12 months)
- Number of Reinterventions Within 12 Months Following the Initial Study Treatment(12 months)
研究者
研究点 (4)
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