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Completed

NCT Number: NCT03596411

The Detection of Barrett's Esophagus by Gastrointestinal Endoscopy Prevents Esophageal Carcinoma in Morbid Obese After Sleeve Gastrectomy

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, Alpes Maritimes, 06001, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 9.
  • 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.

Treatment and study plan

Primary outcomes

  1. Sleeve gastrectomy

    Time frame: 5 years

    Gastroesophageal endoscopic features before and five years after sleeve gastrectomy

Secondary outcomes

  1. Obesity related comorbidity

    Time frame: 5 years

    obesity related comorbidity before and five years or more after sleeve gastrectomy

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Acronym: Refleeve

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2018
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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