High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's… (NCT05229783) | Clinical Trial Compass
CompletedNot Applicable
High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus
France110 participantsStarted 2022-05-11
Plain-language summary
The investigators hypothesize that careful examination of Barrett's esophagus by high-resolution endoscopy combined with virtual chromoendoscopy could replace the Seattle protocol for Barrett's esophagus monitoring and detection of dysplasic lesions, and thus modify existing recommendations.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.