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

• Conditions: Gastroesophageal Reflux

• Registration Number: NCT03596411
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2018-05
• Study Start: 2018-05-17
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-07-20
• Last Update Submitted: 2018-07-20
• Study First Posted: 2018-07-23
• Last Update Posted: 2018-07-23
• Primary Completion: 2023-05-17
• Study Completion: 2023-11-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleeve gastrectomy	5 years	Gastroesophageal endoscopic features before and five years after sleeve gastrectomy

Secondary Outcome Measures

Name	Time	Method
Obesity related comorbidity	5 years	obesity related comorbidity before and five years or more after sleeve gastrectomy

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Alpes Maritimes, France