Local Injection of Collagenase Clostridium Histolyticum (XiapexR) for Refractory Iatrogenic Esophageal Strictures: an Open-label Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of repeat dilations that are required over a timespan of 6 months.
研究概览
简要总结
In this open-label pilot study we want to investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into the esophageal stricture followed by dilation 24 hours later improves the outcome of patients with refractory esophageal anastomotic strictures as compared to dilation alone (standard of care).
详细描述
Local injection of collagenase clostridium histolyticum (XiapexR) for refractory iatrogenic esophageal strictures: an open-label pilot study.
- Objective of the study
To investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into the esophageal stricture followed by dilation 24 hours later improves the outcome of patients with refractory esophageal anastomotic strictures as compared to dilation alone (standard of care). 2. End point(s) and timepoint(s) of evaluation
Primary outcome measure:
Number of repeat dilations that are required over a timespan of 6 months.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-90 years old
- •suffers from dysphagia caused by an iatrogenic esophageal stricture
- •the stricture is amenable for endoscopic dilation
- •the patient has undergone at least 1 previous endoscopic dilation for the same stricture
- •signed the ICF
排除标准
- •the patient is not fluent in Dutch
研究组 & 干预措施
local collagenase
Patients receiving local injection of collagenase (0.9 mg XiapexR) into the esophageals stricture
干预措施: Collagenase histiolyticum (Drug)
结局指标
主要结局
Number of repeat dilations that are required over a timespan of 6 months.
时间窗: 6 months
次要结局
- time to first repeat dilation(6 months)
- complication rate.(6 months)
- Dysphagia score(6 months)