High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus

NCT ID: NCT05229783

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2025-02-19

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 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 :

1. He/she will describe all visible lesions with precise indications of their location on a virgin scheme;

2. 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;

3. He/she will perform the biopsies/resection he/she would have added (if any);

4. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Electronic chromoendoscopy

High-resolution endoscopy combined with virtual chromoendocopy to detect esophageal displasic lesions

Group Type: EXPERIMENTAL

Electronic chromoendoscopy

Intervention Type: PROCEDURE

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 protocol

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)

Group Type: ACTIVE_COMPARATOR

White light endoscopy with Seattle protocol

Intervention Type: PROCEDURE

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)

Interventions

Electronic chromoendoscopy

Inspection of the Barrett's esophagus using the electronic chromoendoscopy modality of the endoscope for the detection of high-grade dysplasia and adenocarcinoma lesions.

Intervention Type: PROCEDURE

White light endoscopy with Seattle protocol

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)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucille QUENEHERVE, Doctor

Role: PRINCIPAL_INVESTIGATOR

CHU de Brest

Locations

Amiens University Hospital

Amiens, , France

Besançon University Hospital

Besançon, , France

Bordeaux University Hospital

Bordeaux, , France

Brest University Hospital

Brest, , France

Private Bercy clinic

Charenton, , France

Limoges University Hospital

Limoges, , France

Lyon University Hospital

Lyon, , France

Nancy University Hospital

Nancy, , France

Nantes University Hospital

Nantes, , France

Nice University Hospital

Nice, , France

Public Assistance - Paris hospitals - Cochin hospital

Paris, , France

Public Assistance- Paris Hospitals - Georges Pompidou European Hospital

Paris, , France

Poitiers University Hospital

Poitiers, , France

Rennes University Hospital

Rennes, , France

Sainte Barbe Clinic

Strasbourg, , France

Countries

France

Other Identifiers

RC21_0411

Identifier Type: -

Identifier Source: org_study_id