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

NCT ID: NCT04656392

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2024-03-11

Brief Summary

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.

Detailed 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.

Conditions

Barrett Esophagus; Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Breath test (eNose) followed by uTNE.

All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.

Group Type: OTHER

Breath test (eNose) followed by uTNE.

Intervention Type: DIAGNOSTIC_TEST

All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.

Interventions

Breath test (eNose) followed by uTNE.

All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Digestive Diseases Foundation

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter D. Siersema, Prof.dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center Nijmegen

Locations

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

110769

Identifier Type: -

Identifier Source: org_study_id