Status:
COMPLETED
High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus
Lead Sponsor:
Nantes University Hospital
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 esopha...
Detailed Description
Barrett's esophagus (BE) is a pre-neoplastic condition that predisposes to dysplasia and adenocarcinoma of the esophagus, a cancer with an increasing incidence and poor prognosis. However, when detect...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05229783
Start Date
May 11 2022
End Date
February 19 2025
Last Update
November 14 2025
Active Locations (15)
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1
Amiens University Hospital
Amiens, France, 80054
2
Besançon University Hospital
Besançon, France, 25030
3
Bordeaux University Hospital
Bordeaux, France, 33604
4
Brest University Hospital
Brest, France, 26609