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

Gastroesophageal Reflux Clinical Trial

— Refleeve  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596411
• Other study ID #: Cohort 2018
• Status: Recruiting
• Start date: May 17, 2018
• Est. completion date: November 17, 2023

Study information

• Verified date: May 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: IANNELLI Antonio, PhD
• Phone: +33492036376
• Email: iannelli.a[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 17, 2023
• Est. primary completion date: May 17, 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Gastroesophageal Reflux

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleeve gastrectomy	Gastroesophageal endoscopic features before and five years after sleeve gastrectomy	5 years
Secondary	Obesity related comorbidity	obesity related comorbidity before and five years or more after sleeve gastrectomy	5 years