Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound
研究概览
简要总结
Children with esophageal atresia who undergo surgical repair are at risk for anastomotic stricture following surgery. Esophageal stricture can be treated with serial endoscopic dilation but may ultimately need surgical resection if the stricture proves refractory to therapy. Several risk factors have been reported for development of recalcitrant stricture, but to date, no studies have specifically examined the relationship between anastomotic thickness and echotexture at time of initial postoperative endoscopy and treatment outcomes. Other risk factors that have been implicated in the development of recalcitrant stricture include gastroesophageal reflux disease, anastomotic leak, long-gap esophageal atresia, and gestational age. Moreover, it is poorly understood how esophageal layers alter and progress with repeated therapeutic dilation. The investigator hypothesize that the initial thickness and echotexture will help determine therapeutic outcome. It will also help us understand the progression of esophageal echotexture following therapeutic dilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 0-21 years old at time of evaluation with a suspected diagnosis of esophageal stricture secondary to esophageal atresia (with or without Tracheoesophageal fistula) post surgical repair
排除标准
- •Patients with pre-diagnosis of eosinophilic esophagitis
- •Patients with pre-diagnosis of congenital esophageal stricture
- •Patients diagnosed with esophageal stricture secondary to caustic ingestion
- •Patient is diagnosed with an esophageal perforation at time of endoscopy
结局指标
主要结局
Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound
时间窗: 2 years
Patients with esophageal atresia following surgical repair will undergo an endoscopic ultrasound procedure to measure esophageal layer thickness and to describe esophageal echo-texture characteristics at the anastomotic site
次要结局
未报告次要终点
研究者
Michael A. Manfredi, MD
Medical Director of Esophageal and Airway Treatment Center, Assistent Professor of Pediatrics
Boston Children's Hospital
