High-resolution Esophageal Manometry

NCT03415893 | Completed DMC

• 1 other identifier: High-resolution manometry
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Esophageal Atresia

Keywords

high-resolution manometry; esophageal atresia; teenagers

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

teenagers with esophageal atresia and surgically repaired

You may qualify if:

• 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

You may not qualify if:

• patients under 12 years old

Sponsors & Collaborators

• Hospital El Cruce: lead

Study Sites (1)

Hospital El Cruce

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• cecilia curvale

  Hospital El Cruce

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 30, 2018
• Study Start: June 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)