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OpenTrials
Completed

NCT Number: NCT02495051

Esophageal Atresia: Metaplasia, Barrett

The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux disease. Because gastroesophageal reflux disease plays a major role in the development of BE by causing repeated mucosal damage, development of BE is a concern even in children and young adults in this specific population. The aim of this study is to assess the prevalence of BE (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had been treated for EA in early infancy. All eligible patients received upper gastrointestinal endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological suspicion of metaplasia was confirmed centrally.

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Key information

Conditions

Gastroesophageal Reflux Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Esophagus, Barrett Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques Universitaires St Luc,, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical history of esophageal atresia (all types, Ladd's classification)

Exclusion criteria

  • No medical history of esophageal atresia
  • Non acceptance to participate from the patient and/or his parents
  • esophageal atresia treated with esophageal replacement (e.g., coloplasty, gastric transposition)

Treatment and study plan

Esophageal biopsies

Procedure

Primary outcomes

  1. presence of gastric and / or intestinal metaplasia diagnosed at histology

    Time frame: during 2 hours of the endoscopy exam

    Prevalence of Barrett's esophagus (gastric and/or intestinal metaplasia) in adolescents treated for esophageal atresia

Secondary outcomes

  1. presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology

    Time frame: during 2 hours of the endoscopy exam

  2. evaluation of the nutritional status

    Time frame: during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)

  3. evaluation of actual symptoms and treatment of gastroesophageal reflux disease

    Time frame: during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)

  4. evaluation of actual other symptoms (respiratory, dysphagia)

    Time frame: during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia

Acronym: Oesophagix

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 13, 2015
Registry last updated
Jul 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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