Barrett EsophagusCONVERSENCT05229783
High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus
A study testing Electronic chromoendoscopy and White light endoscopy with Seattle protocol in people with Barrett Esophagus, run by Nantes University Hospital at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Electronic chromoendoscopy and White light endoscopy with Seattle protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 15 sitesFrance
- Study dates
- 11 May 2022to 19 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Amiens University Hospital
Amiens, 80054
Besançon University Hospital
Besançon, 25030
Bordeaux University Hospital
Bordeaux, 33604
Brest University Hospital
Brest, 26609
Private Bercy clinic
Charenton, 94220
Limoges University Hospital
Limoges, 87000
Lyon University Hospital
Lyon, 69003
Nancy University Hospital
Nancy, 54511
Nantes University Hospital
Nantes, 44093
Nice University Hospital
Nice, 06202
Public Assistance - Paris hospitals - Cochin hospital
Paris, 75014
Public Assistance- Paris Hospitals - Georges Pompidou European Hospital
Paris, 75015
Poitiers University Hospital
Poitiers, 86021
Rennes University Hospital
Rennes, 35033
Sainte Barbe Clinic
Strasbourg, 67000
About this study
Official title: 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
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.
Read the 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 detected at an early stage, superficial lesions can be effectively treated by endoscopic resection. Although BE degeneration remains a rare event, the European Society for Gastrointestinal Endoscopy recommends that BE be followed according to its size. Follow-up consists of a digestive endoscopy with white light examination of the esophagus, targeted biopsies of any visible lesions and quadrantic biopsies every 2 centimeters from the esogastric junction to the top of the BE, at a frequency that depends on the presence of dysplasia and the size of the BE. However, physician adherence to this procedure, known as the Seattle Protocol, is low because : 1) it increases the time required for the endoscopist to examine the patient and therefore the duration of sedation, as well as the time needed to interpret the pathology, 2) the risk of sampling error is high because only a small portion of the esophageal mucosa can be biopsied and 3) this approach is costly because of the time spent on the Seattle protocol in the operating room and in the pathology department.
New optical tools such as high-resolution endoscopy combined with magnification and electronic chromoendoscopy can reveal subtle mucosal and microvascular changes in the BE, which could improve the detection of early neoplastic lesions. However, there is still insufficient evidence to recommend its use in routine BE surveillance.
The investigators hypothesize that careful examination of Barrett's Esophagus by high-resolution endoscopy combined with virtual chromoendoscopy could replace the Seattle protocol for BE monitoring and detection of dysplasic lesions, and thus modify existing recommendations.
In this study, each patient will be his(her) own control and have the two procedures :
- Firstly, an endoscopist called A will perform high-resolution endoscopy combined with virtual chromoendocopy and note on a scheme the biopsies/resection he would have done with this procedure.
- Secondly, another endoscopist called B will do the examination using white light modality of the endoscope and process as follows :
- He/she will describe all visible lesions with precise indications of their location on a virgin scheme;
- Then, he/she will be unblinded to endoscopist A findings, see the scheme of endoscopist A and perform biopsies/resection according to instructions of this scheme;
- He/she will perform the biopsies/resection he/she would have added (if any);
- Finally, he/she will perform the quadrantic biopsies according to Seattle Protocol.
Final histology results will serve as gold standard for the diagnosis of early esophageal adenocarcnoma or high grade displasia.
- Conditions
- Barrett Esophagus
- Being tested
- Electronic chromoendoscopy, White light endoscopy with Seattle protocol
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic chromoendoscopyProcedure or surgery
Inspection of the Barrett's esophagus using the electronic chromoendoscopy modality of the endoscope for the detection of high-grade dysplasia and adenocarcinoma lesions.
White light endoscopy with Seattle protocolProcedure or surgery
Inspection of the Barrett's esophagus using the white light modality of the endoscope for the detection of high-grade dysplasia and adenocarcinoma lesions, and then systemic quadrantic biopsies every 2 centimeters from the esogastric junction to the top of the Barett's esophagus (Seattle protocol)
| Study group | Role | What they receive |
|---|---|---|
| Electronic chromoendoscopy | Experimental | High-resolution endoscopy combined with virtual chromoendocopy to detect esophageal displasic lesions Receives: Procedure: Electronic chromoendoscopy |
| White light endoscopy with Seattle protocol | Active comparator | 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) Receives: Procedure: White light endoscopy with Seattle protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (7)
Rate of both high grade dysplasia and esophageal adenocarcinoma lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy.
Measured: Day 1
Rate of low grade displasia lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy plus systemic biopsies according to Seattle protocol.
Measured: Day 1
Duration (in minutes) of each procedure: white light endoscopy, electronic chromoendoscopy, Seattle protocol.
Measured: Day 1
Rate of missed lesions (both high grade dysplasia and esophageal adenocarcinoma) diagnosed by an adjudication committee reviewing videos from the procedure.
Measured: Day 1
Rate of resected lesions (both high grade dysplasia and esophageal adenocarcinoma) that were detected by endoscopist performing electronic chromoendoscopy, but missed by endoscopist performing white light endoscopy and Seattle protocol.
Measured: Day 1
Number of adverse events
Measured: Day 30
Cost effectiveness of the detection of both early esophageal adenocarcinoma and high grade dysplasia with electronic chromoendoscopy versus cost effectiveness of Seattle protocol.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start11 May 2022
- Primary completion3 Dec 2024
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Each patient will be his (her) own control and have the two procedures : * Firsty : high-resolution endoscopy combined with virtual chromoendocopy (performed by endoscopist A) * Secondly: white light endoscopy with Seattle protocol (performed by endoscopist B)
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucille QUENEHERVE, Doctor, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229783
- Sponsor's protocol ID
- RC21_0411
- Acronym
- CONVERSE
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2021
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Queneherve 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.
PubMed 42420864
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05229783
- Acronym / sponsor ID
- CONVERSE / RC21_0411
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 detected at an early stage, superficial lesions can be effectively treated by endoscopic resection. Although BE degeneration remains a rare event, the European Society for Gastrointestinal Endoscopy recommends that BE be followed according to its size. Follow-up consists of a digestive endoscopy with white light examination of the esophagus, targeted biopsies of any visible lesions and quadrantic biopsies every 2 centimeters from the esogastric junction to the top of the BE, at a frequency that depends on the presence of dysplasia and the size of the BE. However, physician adherence to this procedure, known as the Seattle Protocol, is low because : 1) it increases the time required for the endoscopist to examine the patient and therefore the duration of sedation, as well as the time needed to interpret the pathology, 2) the risk of sampling error is high because only a small portion of the esophageal mucosa can be biopsied and 3) this approach is costly because of the time spent on the Seattle protocol in the operating room and in the pathology department.
New optical tools such as high-resolution endoscopy combined with magnification and electronic chromoendoscopy can reveal subtle mucosal and microvascular changes in the BE, which could improve the detection of early neoplastic lesions. However, there is still insufficient evidence to recommend its use in routine BE surveillance.
The investigators hypothesize that careful examination of Barrett's Esophagus by high-resolution endoscopy combined with virtual chromoendoscopy could replace the Seattle protocol for BE monitoring and detection of dysplasic lesions, and thus modify existing recommendations.
In this study, each patient will be his(her) own control and have the two procedures :
- Firstly, an endoscopist called A will perform high-resolution endoscopy combined with virtual chromoendocopy and note on a scheme the biopsies/resection he would have done with this procedure.
- Secondly, another endoscopist called B will do the examination using white light modality of the endoscope and process as follows :
- He/she will describe all visible lesions with precise indications of their location on a virgin scheme;
- Then, he/she will be unblinded to endoscopist A findings, see the scheme of endoscopist A and perform biopsies/resection according to instructions of this scheme;
- He/she will perform the biopsies/resection he/she would have added (if any);
- Finally, he/she will perform the quadrantic biopsies according to Seattle Protocol.
Final histology results will serve as gold standard for the diagnosis of early esophageal adenocarcnoma or high grade displasia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Each patient will be his (her) own control and have the two procedures : * Firsty : high-resolution endoscopy combined with virtual chromoendocopy (performed by endoscopist A) * Secondly: white light endoscopy with Seattle protocol (performed by endoscopist B)
| Arm | Type | Receives |
|---|---|---|
| Electronic chromoendoscopy | Experimental | Procedure: Electronic chromoendoscopyHigh-resolution endoscopy combined with virtual chromoendocopy to detect esophageal displasic lesions |
| White light endoscopy with Seattle protocol | Active comparator | Procedure: White light endoscopy with Seattle protocolWhite 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic chromoendoscopyInspection of the Barrett's esophagus using the electronic chromoendoscopy modality of the endoscope for the detection of high-grade dysplasia and adenocarcinoma lesions. | Procedure or surgery | Electronic chromoendoscopy |
| White light endoscopy with Seattle protocolInspection of the Barrett's esophagus using the white light modality of the endoscope for the detection of high-grade dysplasia and adenocarcinoma lesions, and then systemic quadrantic biopsies every 2 centimeters from the esogastric junction to the top of the Barett's esophagus (Seattle protocol) | Procedure or surgery | White light endoscopy with Seattle protocol |
Primary outcome
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.
Time frame: Day 1
7 secondary outcomes
Rate of both high grade dysplasia and esophageal adenocarcinoma lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy.
Time frame: Day 1
Rate of low grade displasia lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy plus systemic biopsies according to Seattle protocol.
Time frame: Day 1
Duration (in minutes) of each procedure: white light endoscopy, electronic chromoendoscopy, Seattle protocol.
Time frame: Day 1
Rate of missed lesions (both high grade dysplasia and esophageal adenocarcinoma) diagnosed by an adjudication committee reviewing videos from the procedure.
Time frame: Day 1
Rate of resected lesions (both high grade dysplasia and esophageal adenocarcinoma) that were detected by endoscopist performing electronic chromoendoscopy, but missed by endoscopist performing white light endoscopy and Seattle protocol.
Time frame: Day 1
Number of adverse events
Time frame: Day 30
Cost effectiveness of the detection of both early esophageal adenocarcinoma and high grade dysplasia with electronic chromoendoscopy versus cost effectiveness of Seattle protocol.
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Derived from this study: PubMed 42420864Queneherve 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucille QUENEHERVE, Doctor principal investigator
CHU de Brest
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic chromoendoscopy and White light endoscopy with Seattle protocol in people with Barrett Esophagus, run by Nantes University Hospital at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05229783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.