Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03415893
Other study ID # High-resolution manometry
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04072419 - Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period
Withdrawn NCT03127345 - Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health Phase 2
Completed NCT00226044 - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants. Phase 3
Completed NCT03615495 - Flourishâ„¢ Pediatric Esophageal Atresia
Recruiting NCT05995171 - Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence
Completed NCT04901546 - Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome N/A
Recruiting NCT03730454 - Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair N/A
Recruiting NCT03455881 - Phenotypic and Genetic Assessment of Tracheal and Esophageal Birth Defects in Patients
Completed NCT05527873 - Respiratory Complications of Operated Esophageal Atresia in Children
Completed NCT04932746 - The Effect of Dexmedetomidine on Oxygen During One Lung Ventilation in Pediatric Surgery. N/A
Not yet recruiting NCT04259528 - Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair N/A
Recruiting NCT06073158 - Molecular Signatures of Esophageal Atresia N/A
Not yet recruiting NCT03999008 - Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA) N/A
Not yet recruiting NCT03023865 - Individualized Management for Long Gap Esophageal Atresia N/A
Recruiting NCT02883725 - National Register of Oesophageal Atresia
Not yet recruiting NCT04136795 - Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery
Recruiting NCT03619408 - Management of Esophagitis Following Repair of Esophageal Atresia
Completed NCT05129930 - Fluid Overload and Pulmonary Function
Completed NCT02033772 - Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery N/A
Recruiting NCT03767673 - Cardiorespiratory Performance and Pulmonary Microbiome in Patients After Repair of Esophageal Atresia N/A