Clinical trial NCT05229783: High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Barrett Esophagus
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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)
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: Rate of both high grade dysplasia and esophageal adenocarcinoma lesions detected by electronic chromoendoscopy versus rate of such lesions detected by white light endoscopy.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: Duration (in minutes) of each procedure: white light endoscopy, electronic chromoendoscopy, Seattle protocol.
timeFrame: Day 1
measure: Rate of missed lesions (both high grade dysplasia and esophageal adenocarcinoma) diagnosed by an adjudication committee reviewing videos from the procedure.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: Number of adverse events
timeFrame: Day 30
measure: Cost effectiveness of the detection of both early esophageal adenocarcinoma and high grade dysplasia with electronic chromoendoscopy versus cost effectiveness of Seattle protocol.
timeFrame: Day 30
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
city: Besançon
country: France
facility: Besançon University Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Charenton
country: France
facility: Private Bercy clinic
city: Limoges
country: France
facility: Limoges University Hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Nancy
country: France
facility: Nancy University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Nice
country: France
facility: Nice University Hospital
city: Paris
country: France
facility: Public Assistance - Paris hospitals - Cochin hospital
city: Paris
country: France
facility: Public Assistance- Paris Hospitals - Georges Pompidou European Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Strasbourg
country: France
facility: Sainte Barbe Clinic
Study officials:
affiliation: CHU de Brest
name: Lucille QUENEHERVE, Doctor
role: PRINCIPAL_INVESTIGATOR
References: