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CompletedNCT03415893Updated Jan 31, 2018

High-resolution Esophageal Manometry

An observational study in Esophageal Atresia, sponsored by Hospital El Cruce. Completed at 1 site in Argentina. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-01-31.

Sponsored by Hospital El Cruce · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Esophageal Atresia

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Keywords

  • high-resolution manometry
  • esophageal atresia
  • teenagers
03

In context

Esophageal Atresia

37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 19 observational studies indexed under Esophageal Atresia.

Browse Esophageal Atresia studies →

Lead sponsor

Hospital El Cruce is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

teenagers with esophageal atresia and surgically repaired

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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

Exclusion Criteria:

  • patients under 12 years old
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (actual)
Patient registry
No
06

What researchers measure

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

    Time frame: one day

07

Study locations

1 site
  • Hospital El Cruce
    Florencio Varela, Buenos Aires 1888, Argentina
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in Sep 2017, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Jan 30, 2018
StartActual
Jun 1, 2017
Primary completionActual
Sep 1, 2017
CompletionActual
Dec 1, 2017
Last update
Jan 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03415893
Lead sponsor
Hospital El Cruce
Responsible party
CECILIA CURVALE (PI, Hospital El Cruce) — Principal investigator
First posted
Jan 30, 2018
Start date
Jun 1, 2017
Primary completion
Sep 1, 2017
Completion
Dec 1, 2017
Last update
Jan 31, 2018

Study contacts

cecilia curvale
principal investigator · Hospital El Cruce

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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