Evaluation of Topical Mitomycin C as Adjuvant Drug to Endoscopic Esophageal Dilation in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of days with improved symptom (dysphagia) after dilation session.
研究概览
简要总结
This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures.
This is a crossover, controlled, clinical trial in which children with esophageal stricture will be randomized in two groups to receive either topical mitomycin or no additional treatment during standard esophageal dilation session.
详细描述
Topical mitomycin C has been used as an adjunct drug to endoscopic treatment of aero-digestive strictures. There has been some case reports and case series of this application in esophageal strictures in children, with good results. Nevertheless, it lacks a controlled clinical trial to access the efficacy of the mitomycin C in this context.
This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures.
This is a crossover placebo-controlled single-blind clinical trial.
Patients: Subjects up to 18 year-old, with esophageal stricture requiring endoscopic dilation, either due to dysphagia or by stricture preventing passage of the endoscope.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with esophageal strictures
- •and dysphagia
- •or stricture preventing endoscope to pass over it.
排除标准
- •congenital esophageal stricture
- •stricture associated to eosinophilic esophagitis
研究组 & 干预措施
1
First dilation session with topical mitomycin applied over esophageal mucosa after dilation.
Second dilation session (after 14 days): standard dilation without topical mitomycin.
干预措施: Mitomycin C (Drug)
2
First dilation session: standard dilation without topical mitomycin.
Second dilation session (after 14 days) with topical mitomycin applied over esophageal mucosa after dilation.
干预措施: Mitomycin C (Drug)
结局指标
主要结局
Number of days with improved symptom (dysphagia) after dilation session.
时间窗: 14 days
次要结局
- Esophageal diameter(14 days)