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

NCT05229783 | Completed

• 1 other identifier: RC21_0411
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 15

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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (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.

  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.

  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.

  Day 1

• Duration (in minutes) of each procedure: white light endoscopy, electronic chromoendoscopy, Seattle protocol.

  Day 1

• Rate of missed lesions (both high grade dysplasia and esophageal adenocarcinoma) diagnosed by an adjudication committee reviewing videos from the procedure.

  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.

  Day 1

Study Arms (2)

Electronic chromoendoscopy

EXPERIMENTAL

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

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)

Procedure: White light endoscopy with Seattle protocol

Interventions

Electronic chromoendoscopy 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.

Electronic chromoendoscopy

White light endoscopy with Seattle protocol 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)

White light endoscopy with Seattle protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (15)

Amiens University Hospital

Amiens, 80054, France

Location

Besançon University Hospital

Besançon, 25030, France

Location

Bordeaux University Hospital

Bordeaux, 33604, France

Location

Brest University Hospital

Brest, 26609, France

Location

Private Bercy clinic

Charenton, 94220, France

Location

Limoges University Hospital

Limoges, 87000, France

Location

Lyon University Hospital

Lyon, 69003, France

Location

Nancy University Hospital

Nancy, 54511, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Nice University Hospital

Nice, 06202, France

Location

Public Assistance - Paris hospitals - Cochin hospital

Paris, 75014, France

Location

Public Assistance- Paris Hospitals - Georges Pompidou European Hospital

Paris, 75015, France

Location

Poitiers University Hospital

Poitiers, 86021, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Sainte Barbe Clinic

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Lucille QUENEHERVE, Doctor

  CHU de Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The two endoscopists will be blinded to each other's findings when searching the lesions.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: February 8, 2022
• Study Start: May 11, 2022
• Primary Completion: December 3, 2024
• Study Completion: February 19, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)