Esophageal Atresia: Metaplasia, Barrett

NCT ID: NCT02495051

Last Updated: 2015-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Gastroesophageal Reflux Esophagus, Barrett

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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single group-study

esophageal biopsies

Intervention Type PROCEDURE

Interventions

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esophageal biopsies

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric Gottrand, MD, PhD

Role: STUDY_CHAIR

University Hospital, Lille

Locations

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Cliniques Universitaires St Luc,

Brussels, , Belgium

Site Status

Department of Pediatric Gastroenterology, AZ VUB,

Brussels, , Belgium

Site Status

Department of Pediatric Gastroenterology, HUDERF,

Brussels, , Belgium

Site Status

Department of Gastroenterology CHC, Liège

Liège, , Belgium

Site Status

Hôpital Mère-Enfants Ste Justine, Montréal, Canada

Montreal, , Canada

Site Status

CHU Angers

Angers, , France

Site Status

CHU, Bordeaux

Bordeaux, , France

Site Status

CHU, Caen

Caen, , France

Site Status

Centre Hospitalier

Le Havre, , France

Site Status

University Hospital, Hôpital Jeanne de Flandres

Lille, , France

Site Status

CHU, Lyon

Lyon, , France

Site Status

CHU, Nantes

Nantes, , France

Site Status

AP-HP ,Hôpital Robert Debré,

Paris, , France

Site Status

AP-HP Hôpital Trousseau

Paris, , France

Site Status

CHU, Poitiers

Poitiers, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CH Départemental Félix Guyon,

Saint Denis-La Réunion, , France

Site Status

CHU, Strasbourg

Strasbourg, , France

Site Status

CHU Toulouse,

Toulouse, , France

Site Status

Centre Hospitalier de Luxembourg,

Luxembourg, , Luxembourg

Site Status

Countries

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Belgium Canada France Luxembourg

References

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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.

Reference Type DERIVED
PMID: 26720426 (View on PubMed)

Other Identifiers

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DR-2011-057 / A 910270

Identifier Type: OTHER

Identifier Source: secondary_id

2009/cic

Identifier Type: -

Identifier Source: org_study_id

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