Comparing high-resolution virtual chromoendoscopy to the Seattle protocol for monitoring Barrett's esophagus

High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus: Impact on the Detection of High-grade Dysplasia and Adenocarcinoma Lesions

This study is testing if a new type of high-resolution endoscopy can do a better job than the standard method for monitoring Barrett's esophagus to help catch potential cancer early.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 15 sites (Amiens and 14 other locations)
• Trial ID: NCT05229783 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether high-resolution endoscopy combined with virtual chromoendoscopy can effectively replace the Seattle protocol for monitoring Barrett's esophagus. Barrett's esophagus is a condition that can lead to esophageal cancer, and early detection of dysplastic lesions is crucial for effective treatment. The study will involve patients undergoing endoscopy as part of their regular monitoring, comparing the two methods in terms of efficacy and adherence. The goal is to improve detection rates while reducing the time and costs associated with the current protocol.

Who should consider this trial

Good fit: Ideal candidates include adults with dysplastic Barrett's esophagus who require regular endoscopic monitoring.

Not a fit: Patients with previously treated Barrett's esophagus or known invasive esophageal adenocarcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more efficient and accurate monitoring of Barrett's esophagus, potentially improving patient outcomes.

How similar studies have performed: While the Seattle protocol is well-established, the use of high-resolution virtual chromoendoscopy is a novel approach that has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

* Male or Female with Age above ≥ years old;
* Female of childbearing potential must use appropriate method(s) of contraception during the clinical trial (i.e.: Intrauterine Device, pill, implant,sexual abstinence);
* Dysplastic Barrett's Esophagus preferably labelled "flat mucosal dysplasia";
* Patient requiring esophageal endoscopy as part of their regular monitoring;
* Affiliated to social security;
* Patient received Patient Information Form and accepted to participate to the study.

Exclusion Criteria:

* Previously treated Barrett's Esophagus;
* Known invasive esophageal adenocarcinoma;
* Contraindication to general anesthesia;
* Ongoing clopidogrel or anticoagulant therapy or coagulation disorder (platelet count \< 50 000/mm3, Prothrombin time ratio \<50%);
* Poor general health status precluding subsequent follow up of Barrett's Esophagus ;
* For female: pregnancy or breastfeeding;
* Adults under a legal protection regime (guardianship, trusteeship, "under judicial protection").
* Ongoing participation in another study requiring an intervention on Barrett's Esophagus during patient's participation in Converse study

Where this trial is running

Amiens and 14 other locations

• Amiens University Hospital — Amiens, France (Recruiting)
• Besançon University Hospital — Besançon, France (Recruiting)
• Bordeaux University Hospital — Bordeaux, France (Recruiting)
• Brest University Hospital — Brest, France (Recruiting)
• Private Bercy clinic — Charenton, France (Recruiting)
• Limoges University Hospital — Limoges, France (Recruiting)
• Lyon University Hospital — Lyon, France (Recruiting)
• Nancy University Hospital — Nancy, France (Recruiting)
• Nantes University Hospital — Nantes, France (Recruiting)
• Nice University Hospital — Nice, France (Recruiting)
• Public Assistance - Paris hospitals - Cochin hospital — Paris, France (Recruiting)
• Public Assistance- Paris Hospitals - Georges Pompidou European Hospital — Paris, France (Recruiting)
• Poitiers University Hospital — Poitiers, France (Recruiting)
• Rennes University Hospital — Rennes, France (Recruiting)
• Sainte Barbe Clinic — Strasbourg, France (Recruiting)

Study contacts

• Principal investigator: Lucille QUENEHERVE, Doctor — CHU de Brest
• Study coordinator: QUENEHERVE Lucille, Doctor

Conditions Barrett Esophagus