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

May 30, 2023 updated by: Nantes University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • Amiens university hospital
        • Contact:
      • Besançon, France, 25030
        • Not yet recruiting
        • Besançon University Hospital
        • Contact:
      • Bordeaux, France, 33604
      • Brest, France, 26609
      • Charenton, France, 94220
        • Recruiting
        • Private Bercy clinic
        • Contact:
      • Limoges, France, 87000
        • Recruiting
        • Limoges university hospital
        • Contact:
      • Lyon, France, 69003
        • Recruiting
        • Lyon university hospital
        • Contact:
      • Nancy, France, 54511
        • Not yet recruiting
        • Nancy University Hospital
        • Contact:
      • Nantes, France, 44093
      • Nice, France, 06202
        • Recruiting
        • Nice University Hospital
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Public Assistance - Paris hospitals - Cochin hospital
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • Public Assistance- Paris Hospitals - Georges Pompidou European Hospital
        • Contact:
      • Poitiers, France, 86021
      • Rennes, France, 35033
      • Strasbourg, France, 67000
        • Recruiting
        • Sainte Barbe Clinic
        • Contact:
          • Irina TCHOUMAK, PH
          • Phone Number: +33 3 88 21 70 00

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electronic chromoendoscopy
High-resolution endoscopy combined with virtual chromoendocopy to detect esophageal displasic lesions
Procedure: 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.
Active Comparator: 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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Day 1
Duration (in minutes) of each procedure: white light endoscopy, electronic chromoendoscopy, Seattle protocol.
Time Frame: Day 1
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
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
Day 1
Number of adverse events
Time Frame: Day 30
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
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Lucille QUENEHERVE, Doctor, CHU de Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC21_0411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Barrett Esophagus

Clinical Trials on Electronic chromoendoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe