Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT02495051
Status:
COMPLETED
Last Update Posted:
2015-07-13
First Post:
2015-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Esophageal Atresia: Metaplasia, Barrett
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-10', 'studyFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of gastric and / or intestinal metaplasia diagnosed at histology', 'timeFrame': 'during 2 hours of the endoscopy exam', 'description': "Prevalence of Barrett's esophagus (gastric and/or intestinal metaplasia) in adolescents treated for esophageal atresia"}], 'secondaryOutcomes': [{'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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastroesophageal reflux', 'barrett esophagus'], 'conditions': ['Gastroesophageal Reflux', 'Esophagus, Barrett']}, 'referencesModule': {'references': [{'pmid': '26720426', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medical history of esophageal atresia (all types, Ladd's classification)\n\nExclusion Criteria:\n\n* No medical history of esophageal atresia\n* Non acceptance to participate from the patient and/or his parents\n* esophageal atresia treated with esophageal replacement (e.g., coloplasty, gastric transposition)"}, 'identificationModule': {'nctId': 'NCT02495051', 'acronym': 'Oesophagix', 'briefTitle': 'Esophageal Atresia: Metaplasia, Barrett', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': "Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia", 'orgStudyIdInfo': {'id': '2009/cic'}, 'secondaryIdInfos': [{'id': 'DR-2011-057 / A 910270', 'type': 'OTHER', 'domain': 'CNIL Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'single group-study', 'interventionNames': ['Procedure: esophageal biopsies']}], 'interventions': [{'name': 'esophageal biopsies', 'type': 'PROCEDURE', 'armGroupLabels': ['single group-study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires St Luc,', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Department of Pediatric Gastroenterology, AZ VUB,', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Department of Pediatric Gastroenterology, HUDERF,', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Department of Gastroenterology CHC, Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Hôpital Mère-Enfants Ste Justine, Montréal, Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU, Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU, Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Le Havre', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'city': 'Lille', 'country': 'France', 'facility': 'University Hospital, Hôpital Jeanne de Flandres', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'CHU, Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU, Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP ,Hôpital Robert Debré,', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hôpital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU, Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint Denis-La Réunion', 'country': 'France', 'facility': 'CH Départemental Félix Guyon,'}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU, Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse,', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Luxembourg', 'country': 'Luxembourg', 'facility': 'Centre Hospitalier de Luxembourg,', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}], 'overallOfficials': [{'name': 'Frédéric Gottrand, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}