Viewing Study NCT02495051


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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: University Hospital, Lille
Organization:

Study Overview

Official Title: Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia
Status: COMPLETED
Status Verified Date: 2015-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Oesophagix
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: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
DR-2011-057 / A 910270 OTHER CNIL Number View