Esophageal Atresia: Metaplasia, Barrett (Oesophagix)

July 10, 2015 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Cliniques Universitaires St Luc,
      • Bruxelles, Belgium
        • Department of Pediatric Gastroenterology, AZ VUB,
      • Bruxelles, Belgium
        • Department of Pediatric Gastroenterology, HUDERF,
      • Liège, Belgium
        • Department of Gastroenterology CHC, Liège
  • Canada
      • Montréal, Canada
        • Hôpital Mère-Enfants Ste Justine, Montréal, Canada
  • France
      • Angers, France
        • CHU Angers
      • Bordeaux, France
        • CHU, Bordeaux
      • Caen, France
        • CHU, Caen
      • Le Havre, France
        • Centre Hospitalier
      • Lille, France
        • University Hospital, Hôpital Jeanne de Flandres
      • Lyon, France
        • CHU, Lyon
      • Nantes, France
        • CHU, Nantes
      • Paris, France
        • AP-HP ,Hôpital Robert Debré,
      • Paris, France
        • AP-HP Hôpital Trousseau
      • Poitiers, France
        • CHU, Poitiers
      • Rennes, France
        • CHU Rennes
      • Saint Denis-La Réunion, France
        • CH Départemental Félix Guyon,
      • Strasbourg, France
        • CHU, Strasbourg
      • Toulouse, France
        • CHU Toulouse,
  • Luxembourg
      • Luxembourg, Luxembourg
        • Centre Hospitalier de Luxembourg,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single group-study
Procedure: esophageal biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during 2 hours of the endoscopy exam

Secondary Outcome Measures

Outcome Measure
Time Frame
presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology
Time Frame: during 2 hours of the endoscopy exam
during 2 hours of the endoscopy exam
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)
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
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)
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)
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)
during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Study Chair: Frédéric Gottrand, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 13, 2015

Study Record Updates

Last Update Posted (Estimate)

July 13, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/cic
  • DR-2011-057 / A 910270 (Other Identifier: CNIL Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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