Clinical trial NCT02495051: Esophageal Atresia: Metaplasia, Barrett
Official title: Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Esophagus, Barrett
Keywords: gastroesophageal reflux
barrett esophagus
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: presence of gastric and / or intestinal metaplasia diagnosed at histology
timeFrame: during 2 hours of the endoscopy exam
Secondary outcomes:
measure: presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology
timeFrame: during 2 hours of the endoscopy exam
measure: evaluation of the nutritional status
timeFrame: during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)
measure: evaluation of actual symptoms and treatment of gastroesophageal reflux disease
timeFrame: during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)
measure: evaluation of actual other symptoms (respiratory, dysphagia)
timeFrame: during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc,
city: Bruxelles
country: Belgium
facility: Department of Pediatric Gastroenterology, AZ VUB,
city: Bruxelles
country: Belgium
facility: Department of Pediatric Gastroenterology, HUDERF,
city: Liège
country: Belgium
facility: Department of Gastroenterology CHC, Liège
city: Montréal
country: Canada
facility: Hôpital Mère-Enfants Ste Justine, Montréal, Canada
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU, Bordeaux
city: Caen
country: France
facility: CHU, Caen
city: Le Havre
country: France
facility: Centre Hospitalier
city: Lille
country: France
facility: University Hospital, Hôpital Jeanne de Flandres
city: Lyon
country: France
facility: CHU, Lyon
city: Nantes
country: France
facility: CHU, Nantes
city: Paris
country: France
facility: AP-HP ,Hôpital Robert Debré,
city: Paris
country: France
facility: AP-HP Hôpital Trousseau
city: Poitiers
country: France
facility: CHU, Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Saint Denis-La Réunion
country: France
facility: CH Départemental Félix Guyon,
city: Strasbourg
country: France
facility: CHU, Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse,
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg,
Study officials:
affiliation: University Hospital, Lille
name: Frédéric Gottrand, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.