Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Maximum dilatation size
研究概览
简要总结
This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.
详细描述
Background and study aims: Benign esophageal strictures are primarily treated with dilation therapy, but strictures can recur or can be unresponsive, requiring additional or repeated treatment. This study investigates the efficacy and safety of intralesional steroid injections (ISIs) in addition to dilation in patients with refractory benign esophageal strictures.
Methods: This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.
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
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged less than 14 years
- •with refractory benign esophageal strictures
- •received a dilatation therapy without triamcinolone injections
排除标准
- •failure to pass a guide wire secondary to pharyngeal stenosis
- •tracheo-esophageal fistula
- •those who received triamcinolone injections at early dilatation
结局指标
主要结局
Maximum dilatation size
时间窗: 12 months
achieving a diameter of 11 mm for patients aged \<2 years, 12 mm for patients aged between 2 and 5 years, and 15 mm for children aged \>5 years with complete relief of symptoms without requiring endoscopic procedure or surgical intervention for at least 6 months
次要结局
- dysphagia score(12 months)
研究者
Mohammad Daboos
Professor at Pediatric Surgery Department, Al-Azhar University.
Al-Azhar University