Clinical trial · Interventional
High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of 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
NCT05229783CI-TRIAL-00097200CONVERSEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic chromoendoscopy | Procedure | — | UNRESOLVED |
| White light endoscopy with Seattle protocol | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Electronic chromoendoscopy
- description
- High-resolution endoscopy combined with virtual chromoendocopy to detect esophageal displasic lesions
- interventionNames
- Procedure: Electronic chromoendoscopy
- type
- ACTIVE_COMPARATOR
- label
- White light endoscopy with Seattle protocol
- description
- White light endoscopy to detect esophageal displasic lesions, and then systemic quadrantic biopsies every 2 centimeters from the esogastric junction to the top of the Barett's esophagus (Seattle protocol)
- interventionNames
- Procedure: White light endoscopy with Seattle protocol
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDQueneherve L, Hardouin JB, Riche VP, Compaore Y, Archambeaud I, Bardot S, Alebic IJ, Marguerite M, Letaillandier C, Ratajczak C, Pierry O, Jobert A, Rahmi G, Berger A, Karsenti D, Yzet C, Pioche M, Barrioz T, Tchoumak I, Schaefer M, Chevaux JB, Jacques J, Wallenhorst T, Vanbiervliet G, Koch S, Barret M, Poinas A, Coron E. Detection of high-grade dysplasia and adenocarcinoma in Barrett's esophagus using high-resolution virtual chromoendoscopy versus the Seattle protocol: the CONVERSE study. BMC Gastroenterol. 2026 Jul 8. doi: 10.1186/s12876-026-05038-3. Online ahead of print. PMID 42420864