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临床试验/NCT04259528
NCT04259528Unknown不适用

Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Boston Children's Hospital0 个研究点目标入组 50 人开始时间: 2020年3月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael A. Manfredi, MD

Medical Director of Esophageal and Airway Treatment Center, Assistent Professor of Pediatrics

Boston Children's Hospital

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