Esophageal Atresia: Metaplasia, Barrett
Oesophagix
Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia
2 other identifiers
observational
120
4 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2010
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
July 13, 2015
CompletedJuly 13, 2015
July 1, 2015
3.1 years
June 22, 2015
July 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
presence of gastric and / or intestinal metaplasia diagnosed at histology
Prevalence of Barrett's esophagus (gastric and/or intestinal metaplasia) in adolescents treated for esophageal atresia
during 2 hours of the endoscopy exam
Secondary Outcomes (4)
presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology
during 2 hours of the endoscopy exam
evaluation of the nutritional status
during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)
evaluation of actual symptoms and treatment of gastroesophageal reflux disease
during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)
evaluation of actual other symptoms (respiratory, dysphagia)
during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)
Study Arms (1)
single group-study
Interventions
Eligibility Criteria
All esophageal atresia patients treated in 20 centers that participated in the French-speaking Group of Gastroenterology, Hepatology, and Nutrition and/or were members of the esophageal atresia national registry
You may qualify if:
- Medical history of esophageal atresia (all types, Ladd's classification)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Cliniques Universitaires St Luc,
Brussels, Belgium
Department of Pediatric Gastroenterology, AZ VUB,
Brussels, Belgium
Department of Pediatric Gastroenterology, HUDERF,
Brussels, Belgium
Department of Gastroenterology CHC, Liège
Liège, Belgium
Hôpital Mère-Enfants Ste Justine, Montréal, Canada
Montreal, Canada
CHU Angers
Angers, France
CHU, Bordeaux
Bordeaux, France
CHU, Caen
Caen, France
Centre Hospitalier
Le Havre, France
University Hospital, Hôpital Jeanne de Flandres
Lille, France
CHU, Lyon
Lyon, France
CHU, Nantes
Nantes, France
AP-HP ,Hôpital Robert Debré,
Paris, France
AP-HP Hôpital Trousseau
Paris, France
CHU, Poitiers
Poitiers, France
CHU Rennes
Rennes, France
CH Départemental Félix Guyon,
Saint Denis-La Réunion, France
CHU, Strasbourg
Strasbourg, France
CHU Toulouse,
Toulouse, France
Centre Hospitalier de Luxembourg,
Luxembourg, Luxembourg
Related Publications (1)
Schneider A, Gottrand F, Bellaiche M, Becmeur F, Lachaux A, Bridoux-Henno L, Michel JL, Faure C, Philippe P, Vandenplas Y, Dupont C, Breton A, Gaudin J, Lamireau T, Muyshont L, Podevin G, Viola S, Bertrand V, Caldari D, Colinet S, Wanty C, Sauleau E, Leteurtre E, Michaud L. Prevalence of Barrett Esophagus in Adolescents and Young Adults With Esophageal Atresia. Ann Surg. 2016 Dec;264(6):1004-1008. doi: 10.1097/SLA.0000000000001540.
PMID: 26720426DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Frédéric Gottrand, MD, PhD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2015
First Posted
July 13, 2015
Study Start
February 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 13, 2015
Record last verified: 2015-07