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临床试验/NCT03415893
NCT03415893已完成不适用

High-resolution Esophageal Manometry in Teenagers With Esophageal Atresia

Hospital El Cruce1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Patterns of High Resolution Manometry in teenagers with esophageal atresia

研究概览

简要总结

EA is one of the most frequent birth defects, with an incidence of 1 in 3000 live births1. Until the 1950s, these patients had 100% mortality; nowadays, the survival rate is greater than 90%, and only those with associated severe malformations die1-5.

Type C EA (atresia of the esophageal proximal segment with tracheoesophageal fistula between the trachea and the distal segment) is the most common variant, since it is present in 85% of the cases6-8. There is evidence that the esophageal motor disorder present in these children is secondary to a congenital neuromuscular disorder and a postoperative disorder9-14. Patients that survive the operation have greater risk of developing gastroesophageal reflux disease (GERD), caused by anomalies in the esophageal motility and its resulting delay in the evacuation of acid of the esophageal lumen.

There was a hypothesis that suggested that motility alteration could contribute to dysphagia and to the high prevalence of gastroesophageal reflux in these patients15-18. Also, there were reports of a greater incidence of severe esophagitis with requirement of fundoplication, which shows a larger failure rate17-18. Esophageal dysmotility has been proved in children with EA through performance of conventional perfusion manometry.

Lemoine C et al described three motility alteration patterns with HRM in children with repaired EA. Said study allowed a more precise knowledge of segmental esophageal motility19. Currently, there are no reports exclusively made about teenagers with repaired EA that describe segmental esophageal motility with HRM.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • teenagers of more than 12 years old, with repaired EA, orally fed during the last 6 months, with no history of esophageal blockage or dilations, who underwent a HREM

排除标准

  • patients under 12 years old

结局指标

主要结局

Patterns of High Resolution Manometry in teenagers with esophageal atresia

时间窗: one day

Number of patients with patterns of complete aperistalsis, pressurization and distal esophageal contraction in High Resolution Manometry

次要结局

未报告次要终点

研究者

发起方
Hospital El Cruce
申办方类型
Other
责任方
Principal Investigator
主要研究者

CECILIA CURVALE

PI

Hospital El Cruce

研究点 (1)

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