Esophageal Atresia: Metaplasia, Barrett

Completed

• Conditions: Esophagus, Barrett; Gastroesophageal Reflux
• Interventions: Procedure: esophageal biopsies

• Registration Number: NCT02495051
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2015-06-22
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-10
• Last Update Submitted: 2015-07-10
• Study First Posted: 2015-07-13
• Last Update Posted: 2015-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single group-study	esophageal biopsies	-

Primary Outcome Measures

Name	Time	Method
presence of gastric and / or intestinal metaplasia diagnosed at histology	during 2 hours of the endoscopy exam	Prevalence of Barrett's esophagus (gastric and/or intestinal metaplasia) in adolescents treated for esophageal atresia

Secondary Outcome Measures

Name	Time	Method
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)
presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology	during 2 hours of the endoscopy exam
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)

Trial Locations

Locations (20)

Cliniques Universitaires St Luc,; 🇧🇪 Bruxelles, Belgium

Department of Pediatric Gastroenterology, AZ VUB,; 🇧🇪 Bruxelles, Belgium

Centre Hospitalier de Luxembourg,; 🇱🇺 Luxembourg, Luxembourg

Department of Pediatric Gastroenterology, HUDERF,; 🇧🇪 Bruxelles, Belgium

Department of Gastroenterology CHC, Liège; 🇧🇪 Liège, Belgium

AP-HP ,Hôpital Robert Debré,; 🇫🇷 Paris, France

CH Départemental Félix Guyon,; 🇫🇷 Saint Denis-La Réunion, France

AP-HP Hôpital Trousseau; 🇫🇷 Paris, France

CHU Angers; 🇫🇷 Angers, France

CHU, Nantes; 🇫🇷 Nantes, France

CHU Rennes; 🇫🇷 Rennes, France

CHU Toulouse,; 🇫🇷 Toulouse, France

Hôpital Mère-Enfants Ste Justine, Montréal, Canada; 🇨🇦 Montréal, Canada

CHU, Caen; 🇫🇷 Caen, France

CHU, Poitiers; 🇫🇷 Poitiers, France

CHU, Strasbourg; 🇫🇷 Strasbourg, France

CHU, Bordeaux; 🇫🇷 Bordeaux, France

CHU, Lyon; 🇫🇷 Lyon, France

Centre Hospitalier; 🇫🇷 Le Havre, France

University Hospital, Hôpital Jeanne de Flandres; 🇫🇷 Lille, France