Skip to main content
Clinical Trials/NCT03596411
NCT03596411
Unknown
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country100 target enrollmentMay 17, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastroesophageal Reflux
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
100
Locations
1
Primary Endpoint
Sleeve gastrectomy
Last Updated
7 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
May 17, 2018
End Date
November 17, 2023
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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
  • Endoscopic biopsies according to the international guidelines for the diagnosis of Barrett's esophagus 9.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Sleeve gastrectomy

Time Frame: 5 years

Gastroesophageal endoscopic features before and five years after sleeve gastrectomy

Secondary Outcomes

  • Obesity related comorbidity(5 years)

Study Sites (1)

Loading locations...

Similar Trials