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

Last updated: August 22, 2024
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Treatment

Electronic chromoendoscopy

White light endoscopy with Seattle protocol

Clinical Study ID

NCT05229783
RC21_0411
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female with Age above ≥ years old;

  • Female of childbearing potential must use appropriate method(s) of contraceptionduring the clinical trial (i.e.: Intrauterine Device, pill, implant,sexualabstinence);

  • 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

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 judicialprotection").

  • Ongoing participation in another study requiring an intervention on Barrett'sEsophagus during patient's participation in Converse study

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Electronic chromoendoscopy
Phase:
Study Start date:
May 11, 2022
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Amiens University Hospital

    Amiens, 80054
    France

    Active - Recruiting

  • Besançon University Hospital

    Besançon, 25030
    France

    Active - Recruiting

  • Bordeaux University Hospital

    Bordeaux, 33604
    France

    Active - Recruiting

  • Brest University Hospital

    Brest, 26609
    France

    Active - Recruiting

  • Private Bercy clinic

    Charenton, 94220
    France

    Active - Recruiting

  • Limoges University Hospital

    Limoges, 87000
    France

    Active - Recruiting

  • Lyon University Hospital

    Lyon, 69003
    France

    Active - Recruiting

  • Private Jean Mermoz Hospital

    Lyon, 69008
    France

    Site Not Available

  • Nancy University Hospital

    Nancy, 54511
    France

    Active - Recruiting

  • Nantes University Hospital

    Nantes, 44093
    France

    Active - Recruiting

  • Nice University Hospital

    Nice, 06202
    France

    Active - Recruiting

  • Public Assistance - Paris hospitals - Cochin hospital

    Paris, 75014
    France

    Active - Recruiting

  • Public Assistance- Paris Hospitals - Georges Pompidou European Hospital

    Paris, 75015
    France

    Active - Recruiting

  • Saint-Antoine Hospital

    Paris, 75012
    France

    Site Not Available

  • Poitiers University Hospital

    Poitiers, 86021
    France

    Active - Recruiting

  • Rennes University Hospital

    Rennes, 35033
    France

    Active - Recruiting

  • Sainte Barbe Clinic

    Strasbourg, 67000
    France

    Active - Recruiting

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