Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy (ULSBE)

Erasmus University

Status: Not yet enrolling

Conditions: Barrett Esophagus

Treatments: Device: EndoSign

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06720636

NL87577.078.24

Details and patient eligibility

About

The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.

Full description

In this study we will investigate the concordance between the Endosign capsule sponge test and esophagogastroduodenoscopy (EGD) by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma (EAC) in patients with an ultralong-segment Barrett's esophagus. Patients will receive both the Endosign test and an EGD, after which we will compare both outcomes. To detect dysplasia and/or EAC on the cells collected by the Endosign test, we will look at cellular atypia and use p53 immunohistochemistry and novel biomarkers. In the future the Endosign test could perhaps replace EGD in the surveillance of Barrett's esophagus patients.

Enrollment: 137 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy
• Ability to provide informed consent

Exclusion criteria

• Individuals with a diagnosis of an oro-pharynx, esophageal or gastro-esophageal tumor (T2 staging and above), or symptoms of dysphagia
• Esophageal varices or stricture requiring dilatation of the esophagus
• Individuals who have had a cerebrovascular event < 6 months prior where their swallowing has been affected
• Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation (RFA) or Argon Plasma Coagulation (APC) for dysplastic Barrett's esophagus
• Participants who are unable to provide informed consent
• Participants under age 18 years

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

Study group

Experimental group

Description:

Subjects will receive the EndoSign test prior to their scheduled clinically indicated upper endoscopy by an expert endoscopist, per routine standard of care. Additional biopsies will be taken and 10cc of blood will be collected from the cannula used for sedation. Subjects will also receive three questionnaires regarding baseline characteristics, gastrointestinal symptoms and acceptability.

Treatment:

Device: EndoSign