Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care (ELECTRONIC)

Radboud University Medical Center

Status

Completed

Conditions

Esophageal Cancer

Barrett Esophagus

Treatments

Diagnostic Test: Breath test (eNose) followed by uTNE.

Study type

Interventional

Funder types

Other

Identifiers

NCT04656392

110769

Details and patient eligibility

About

In the Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.

Full description

The ongoing increasing incidence of esophageal adenocarcinoma (EAC) in the Netherlands during the last few decades and the still dismal prognosis has stimulated interest in screening for Barrett's esophagus (BE). Although BE is a known precursor of EAC, a minority of patients with EAC (<10%) are known with a previous diagnosis of BE, and hence, most cases of BE are undiagnosed. Screening programs to detect BE followed by endoscopic surveillance and treatment of dysplasia or early neoplasia seem able to reduce the incidence of EAC and improve survival. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. uTNE offers the possibility of a more acceptable and accurate endoscopic assessment of the esophagus with almost neglectable risks and lower costs compared to conventional endoscopy. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.

Enrollment

449 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient aged 50 to 75 years;
Recorded diagnosis of reflux symptoms >90 days OR
Recorded prescriptions for acid suppressant therapy for this indication for at least 1 year in the past 5 years
Written informed consent.

Exclusion criteria

Upper endoscopy in the previous 5 years;
A current or previous diagnosis and/or treatment of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) within the last five years;
Already known with a diagnosis of Barrett's esophagus or gastro-esophageal cancer;
Any argument provided by a patient's own general practitioner not to include the patient;
Comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).