High-resolution Esophageal Manometry

Esophageal Atresia Clinical Trial

Official title:

High-resolution Esophageal Manometry in Teenagers With Esophageal Atresia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415893
• Other study ID #: High-resolution manometry
• Status: Completed
• Phase: N/A
• First received: January 22, 2018
• Last updated: January 30, 2018
• Start date: June 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2018
• Source: Hospital El Cruce
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients under 12 years old

Related Conditions & MeSH terms

• Esophageal Atresia

Locations

Country	Name	City	State
Argentina	Hospital El Cruce	Florencio Varela	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital El Cruce

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns of High Resolution Manometry in teenagers with esophageal atresia	Number of patients with patterns of complete aperistalsis, pressurization and distal esophageal contraction in High Resolution Manometry	one day