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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Reflux

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: IANNELLI Antonio, PhD; Phone Number: +33492036376; Email: iannelli.a@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06001
      • Recruiting
      • Chu de Nice
      • Contact: IANNELLLI, PhD; Phone Number: +33492036376; Email: iannelli.a@chu-nice.fr
      • Principal Investigator: Iannelli Antonio, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Gastroesophagal reflux disease (GERD) in morbid obese after sleeve gastrectomy

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleeve gastrectomy	Gastroesophageal endoscopic features before and five years after sleeve gastrectomy	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obesity related comorbidity	obesity related comorbidity before and five years or more after sleeve gastrectomy	5 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: IANNELLI Antonio, PhD, Chirurgie Digestive, CHU de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Anticipated): May 17, 2023
• Study Completion (Anticipated): November 17, 2023

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Esophageal Neoplasms
• Other Study ID Numbers: Cohort 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No