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

Barrett Esophagus Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Barrett Esophagus

• NCT number: NCT05229783
• Study type: Interventional
• Source: Nantes University Hospital
• Contact: QUENEHERVE Lucille, Doctor
• Phone: +33 2 98 34 71 16
• Email: Lucille.queneherve@chu-brest.fr
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Completion date: September 30, 2025