Clinical Trials Directory

Trials / Completed

CompletedNCT03415893

High-resolution Esophageal Manometry

High-resolution Esophageal Manometry in Teenagers With Esophageal Atresia

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
Hospital El Cruce · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2017-06-01
Primary completion
2017-09-01
Completion
2017-12-01
First posted
2018-01-30
Last updated
2018-01-31

Locations

1 site across 1 country: Argentina

Source: ClinicalTrials.gov record NCT03415893. Inclusion in this directory is not an endorsement.