|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
3 August 2015 |
|
Main ID: |
NCT02495051 |
|
Date of registration:
|
22/06/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Esophageal Atresia: Metaplasia, Barrett
Oesophagix |
|
Scientific title:
|
Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia |
|
Date of first enrolment:
|
February 2010 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02495051 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Belgium
|
Canada
|
France
|
Luxembourg
| | | | |
|
Contacts
|
|
Name:
|
Frédéric Gottrand, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Lille |
| | |
|
Key inclusion & exclusion criteria
|
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)
Age minimum:
15 Years
Age maximum:
19 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Esophagus, Barrett
|
|
Gastroesophageal Reflux
|
|
Intervention(s)
|
|
Procedure: esophageal biopsies
|
|
Primary Outcome(s)
|
|
presence of gastric and / or intestinal metaplasia diagnosed at histology
[Time Frame: during 2 hours of the endoscopy exam]
|
|
Secondary Outcome(s)
|
|
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)]
|
|
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)]
|
|
presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology
[Time Frame: 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)]
|
|
Secondary ID(s)
|
|
2009/cic
|
|
DR-2011-057 / A 910270
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|