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

NCT03596411 | Completed

• 1 other identifier: Cohort 2018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Sleeve gastrectomy

  Gastroesophageal endoscopic features before and five years after sleeve gastrectomy

  5 years

Secondary Outcomes (1)

• Obesity related comorbidity

  5 years

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06001, France

Location

Related Publications (1)

• Bulsei J, Chierici A, Alifano M, Castaldi A, Drai C, De Fatico S, Rosso E, Fontas E, Iannelli A. Bariatric surgery reduces the risk of pancreatic cancer in individuals with obesity before the age of 50 years: A nationwide administrative data study in France. Eur J Surg Oncol. 2023 Apr;49(4):788-793. doi: 10.1016/j.ejso.2022.11.013. Epub 2022 Nov 9.

  PMID: 36376141 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• IANNELLI Antonio, PhD

  Chirurgie Digestive, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: July 23, 2018
• Study Start: May 17, 2018
• Primary Completion: May 17, 2024
• Study Completion: November 17, 2024
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FR (1)