Gastroesophageal RefluxRefleeveNCT03596411
The Detection of Barrett's Esophagus by Gastrointestinal Endoscopy Prevents Esophageal Carcinoma in Morbid Obese After Sleeve Gastrectomy
An observational study of Gastroesophageal Reflux, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Severe Gastroesophageal reflux disease (GERD) leading to a chronic aggression of esophagus mucosa, called Barrett's esophagus is a main complication of Sleeve gastrectomy for morbid obesity. Barrett's esophagus is considered as a early stage of neoplastic transformation to adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroesophageal Reflux
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2018to 17 Nov 2024
- 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 18 to 60 years
- All sexes
- Adult
Study population: Gastroesophagal reflux disease (GERD) in morbid obese after sleeve gastrectomy
Who may be able to join
- Patients who had had SG with a minimum follow-up of 5 years, without signs of Barrett's esophagus before SG;
- An upper GI endoscopy before the SG;
- An upper GI endoscopy indicating that no Barrett's esophagus was present at the time of the SG;
- An upper GI endoscopy done with the scope of searching for the endoscopic anomalies of the Barrett's esophagus according to the international guidelines for the diagnosis of Barrett's esophagus 9.
- Endoscopic biopsies according to the international guidelines for the diagnosis of Barrett's esophagus 9.
Who cannot join
- SG as a conversional procedure from another bariatric procedure such as the gastric banding;
- No upper GI endoscopy before the SG
- Barrett's esophagus before the SG;
- A second procedure after the SG such as the conversion to Roux-en-Y gastric bypass or duodenal switch;
- An upper GI endoscopy done not following the international guidelines for the diagnosis of Barrett's esophagus9.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refleeve : A Retrospective Study to Evaluate the Prevalence of the Barett's Esophagus by Gastro-osephagal Endoscopy in Morbid Obese Patients Treated by Sleeve Gastrectomy and the Advantage of the Systematic Detection in the Prevention of Esophageal Carcinoma
Severe Gastroesophageal reflux disease (GERD) leading to a chronic aggression of esophagus mucosa, called Barrett's esophagus is a main complication of Sleeve gastrectomy for morbid obesity. Barrett's esophagus is considered as a early stage of neoplastic transformation to adenocarcinoma. Since this last years, six european bariatric centers have adopted the policy to realize endoscopy before and five years or more after sleeve gastrectomy. Investigators worked out a database comprizing the Endoscopic features and patient characteristics. Refleeve projet aim to analyse the long term follow-up datas of 100 patients, evaluate the prevalence of Barret's esophagus and investigate the advantage of the systemetic detection to prevent esophagus adenocarcinomas.
- Conditions
- Gastroesophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleeve gastrectomy
Gastroesophageal endoscopic features before and five years after sleeve gastrectomy
Measured: 5 years
Secondary outcomes (1)
Obesity related comorbidity
obesity related comorbidity before and five years or more after sleeve gastrectomy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start17 May 2018
- Primary completion17 May 2024
- Study completion17 Nov 2024
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 Centre Hospitalier Universitaire de NiceThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IANNELLI Antonio, PhD, Principal investigator, Chirurgie Digestive, CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596411
- Sponsor's protocol ID
- Cohort 2018
- Acronym
- Refleeve
- Status last verified
- Jun 2026
- First submitted
- 17 May 2018
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bulsei J, Chierici A, Alifano M, Castaldi A, Drai C, De Fatico S, Rosso E, Fontas E, Iannelli A. Bariatric surgery reduces the risk of pancreatic cancer in individuals with obesity before the age of 50 years: A nationwide administrative data study in France. Eur J Surg Oncol. 2023 Apr;49(4):788-793. doi: 10.1016/j.ejso.2022.11.013. Epub 2022 Nov 9.
PubMed 36376141
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refleeve : A Retrospective Study to Evaluate the Prevalence of the Barett's Esophagus by Gastro-osephagal Endoscopy in Morbid Obese Patients Treated by Sleeve Gastrectomy and the Advantage of the Systematic Detection in the Prevention of Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT03596411
- Acronym / sponsor ID
- Refleeve / Cohort 2018
- Conditions
- Gastroesophageal Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 Nov 2024 (actual)
- First posted
- 23 Jul 2018 (actual)
- 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.
Severe Gastroesophageal reflux disease (GERD) leading to a chronic aggression of esophagus mucosa, called Barrett's esophagus is a main complication of Sleeve gastrectomy for morbid obesity. Barrett's esophagus is considered as a early stage of neoplastic transformation to adenocarcinoma. Since this last years, six european bariatric centers have adopted the policy to realize endoscopy before and five years or more after sleeve gastrectomy. Investigators worked out a database comprizing the Endoscopic features and patient characteristics. Refleeve projet aim to analyse the long term follow-up datas of 100 patients, evaluate the prevalence of Barret's esophagus and investigate the advantage of the systemetic detection to prevent esophagus adenocarcinomas.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Gastroesophagal reflux disease (GERD) in morbid obese after sleeve gastrectomy
Key inclusion criteria (5 listed)
- Patients who had had SG with a minimum follow-up of 5 years, without signs of Barrett's esophagus before SG;
- An upper GI endoscopy before the SG;
- An upper GI endoscopy indicating that no Barrett's esophagus was present at the time of the SG;
- An upper GI endoscopy done with the scope of searching for the endoscopic anomalies of the Barrett's esophagus according to the international guidelines for the diagnosis of Barrett's esophagus 9.
- Endoscopic biopsies according to the international guidelines for the diagnosis of Barrett's esophagus 9.
Key exclusion criteria (5 listed)
- SG as a conversional procedure from another bariatric procedure such as the gastric banding;
- No upper GI endoscopy before the SG
- Barrett's esophagus before the SG;
- A second procedure after the SG such as the conversion to Roux-en-Y gastric bypass or duodenal switch;
- An upper GI endoscopy done not following the international guidelines for the diagnosis of Barrett's esophagus9.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleeve gastrectomy
Time frame: 5 years
Gastroesophageal endoscopic features before and five years after sleeve gastrectomy
1 secondary outcome
Obesity related comorbidity
Time frame: 5 years
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 17 Jun 2026.
- Results publication: PubMed 36376141Bulsei J, Chierici A, Alifano M, Castaldi A, Drai C, De Fatico S, Rosso E, Fontas E, Iannelli A. Bariatric surgery reduces the risk of pancreatic cancer in individuals with obesity before the age of 50 years: A nationwide administrative data study in France. Eur J Surg Oncol. 2023 Apr;49(4):788-793. doi: 10.1016/j.ejso.2022.11.013. Epub 2022 Nov 9.
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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.
IANNELLI Antonio, PhD principal investigator
Chirurgie Digestive, CHU de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 inclusion and 5 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Sleeve gastrectomy (time frame: 5 years). 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 NCT03596411, 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 17 Jun 2026.