Esophageal Atresia: Metaplasia, Barrett

Gastroesophageal Reflux Clinical Trial

— Oesophagix  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495051
• Other study ID #: 2009/cic
• Secondary ID: DR-2011-057 / A
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: July 10, 2015
• Start date: February 2010
• Est. completion date: March 2013

Study information

• Verified date: July 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 19 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Atresia
• Esophagus, Barrett
• Gastroesophageal Reflux

Intervention

Procedure:
• esophageal biopsies

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc,	Bruxelles
Belgium	Department of Pediatric Gastroenterology, AZ VUB,	Bruxelles
Belgium	Department of Pediatric Gastroenterology, HUDERF,	Bruxelles
Belgium	Department of Gastroenterology CHC, Liège	Liège
Canada	Hôpital Mère-Enfants Ste Justine, Montréal, Canada	Montréal
France	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
Luxembourg	Centre Hospitalier de Luxembourg,	Luxembourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology		during 2 hours of the endoscopy exam	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes