Gastroesophageal RefluxOesophagixNCT02495051
Esophageal Atresia: Metaplasia, Barrett
An observational study of Gastroesophageal Reflux and Esophagus, Barrett, run by University Hospital, Lille at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Gastroesophageal Reflux, Esophagus, Barrett
- What is being tested?
- esophageal biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Feb 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Medical history of esophageal atresia (all types, Ladd's classification)
Who cannot join
- 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)
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
France14 sites
CHU Angers
Angers
CHU, Bordeaux
Bordeaux
CHU, Caen
Caen
Centre Hospitalier
Le Havre
University Hospital, Hôpital Jeanne de Flandres
Lille
CHU, Lyon
Lyon
CHU, Nantes
Nantes
AP-HP ,Hôpital Robert Debré,
Paris
AP-HP Hôpital Trousseau
Paris
CHU, Poitiers
Poitiers
CHU Rennes
Rennes
CH Départemental Félix Guyon,
Saint Denis-La Réunion
CHU, Strasbourg
Strasbourg
CHU Toulouse,
Toulouse
Belgium4 sites
Cliniques Universitaires St Luc,
Brussels
Department of Pediatric Gastroenterology, AZ VUB,
Brussels
Department of Pediatric Gastroenterology, HUDERF,
Brussels
Department of Gastroenterology CHC, Liège
Liège
About this study
Official title: 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.
- Conditions
- Gastroesophageal Reflux, Esophagus, Barrett
- Being tested
- esophageal biopsies
- Keywords
- gastroesophageal reflux, barrett esophagus
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophageal biopsiesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| single group-study | Not described Receives: Procedure: esophageal biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of gastric and / or intestinal metaplasia diagnosed at histology
Prevalence of Barrett's esophagus (gastric and/or intestinal metaplasia) in adolescents treated for esophageal atresia
Measured: during 2 hours of the endoscopy exam
Secondary outcomes (4)
presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology
Measured: during 2 hours of the endoscopy exam
evaluation of the nutritional status
Measured: 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
Measured: 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)
Measured: during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startFeb 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Gottrand, MD, PhD, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495051
- Sponsor's protocol ID
- 2009/cic
- Other IDs
- DR-2011-057 / A 910270
- Acronym
- Oesophagix
- Status last verified
- Jul 2015
- First submitted
- 22 Jun 2015
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26720426
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia
- ClinicalTrials.gov ID
- NCT02495051
- Acronym / sponsor ID
- Oesophagix / 2009/cic
- Conditions
- Gastroesophageal Reflux, Esophagus, Barrett
- Keywords
- gastroesophageal reflux, barrett esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group-study | – | Procedure: esophageal biopsies |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Medical history of esophageal atresia (all types, Ladd's classification)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esophageal biopsies | Procedure or surgery | single group-study |
Primary outcome
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
4 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Derived from this study: PubMed 26720426Schneider 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Gottrand, MD, PhD study chair
University Hospital, Lille
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux and Esophagus, Barrett, run by University Hospital, Lille at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Belgium, Canada, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of gastric and / or intestinal metaplasia diagnosed at histology (time frame: during 2 hours of the endoscopy exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.