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

Barrett Esophagus Clinical Trial

— CONVERSE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229783
• Other study ID #: RC21_0411
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2023
• Source: Nantes University Hospital
• Contact: QUENEHERVE Lucille, Doctor
• Phone: +33 2 98 34 71 16
• Email: Lucille.queneherve[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

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.
• 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)

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Duration (in minutes) of each procedure: white light endoscopy, electronic chromoendoscopy, Seattle protocol.		Day 1
Secondary	Rate of missed lesions (both high grade dysplasia and esophageal adenocarcinoma) diagnosed by an adjudication committee reviewing videos from the procedure.		Day 1
Secondary	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
Secondary	Number of adverse events		Day 30
Secondary	Cost effectiveness of the detection of both early esophageal adenocarcinoma and high grade dysplasia with electronic chromoendoscopy versus cost effectiveness of Seattle protocol.		Day 30