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

NCT ID: NCT03596411

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-17

Study Completion Date

2023-11-17

Brief Summary

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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

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Conditions

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Gastroesophageal Reflux

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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IANNELLI Antonio, PhD

Role: PRINCIPAL_INVESTIGATOR

Chirurgie Digestive, CHU de Nice

Locations

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CHU de Nice

Nice, Alpes Maritimes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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IANNELLI Antonio, PhD

Role: CONTACT

+33492036376

Facility Contacts

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IANNELLLI, PhD

Role: primary

+33492036376

Other Identifiers

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Cohort 2018

Identifier Type: -

Identifier Source: org_study_id

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