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

C

Centre Hospitalier Universitaire de Nice

Status

Unknown

Conditions

Gastroesophageal Reflux

Study type

Observational

Funder types

Other

Identifiers

NCT03596411
Cohort 2018

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

IANNELLI Antonio, PhD

Data sourced from clinicaltrials.gov

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