High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus

Not Applicable

Recruiting

• Conditions: Barrett Esophagus

• Registration Number: NCT05229783
• Lead Sponsor: Nantes University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Inclusion Criteria:<br><br> - Male or Female with Age above = years old;<br><br> - Female of childbearing potential must use appropriate method(s) of contraception<br> during the clinical trial (i.e.: Intrauterine Device, pill, implant,sexual<br> abstinence);<br><br> - Dysplastic Barrett's Esophagus preferably labelled flat mucosal dysplasia;<br><br> - Patient requiring esophageal endoscopy as part of their regular monitoring;<br><br> - Affiliated to social security;<br><br> - Patient received Patient Information Form and accepted to participate to the study.<br><br>Exclusion Criteria:<br><br> - Previously treated Barrett's Esophagus;<br><br> - Known invasive esophageal adenocarcinoma;<br><br> - Contraindication to general anesthesia;<br><br> - Ongoing clopidogrel or anticoagulant therapy or coagulation disorder (platelet count<br> < 50 000/mm3, Prothrombin time ratio <50%);<br><br> - Poor general health status precluding subsequent follow up of Barrett's Esophagus ;<br><br> - For female: pregnancy or breastfeeding;<br><br> - Adults under a legal protection regime (guardianship, trusteeship, under judicial<br> protection).<br><br> - Ongoing participation in another study requiring an intervention on Barrett's<br> Esophagus during patient's participation in Converse study

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of both high grade dysplasia and esophageal adenocarcinoma lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy plus systemic biopsies according to Seattle protocol.