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

NCT04656392 | Completed

• 1 other identifier: 110769
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus; Esophageal Cancer

Keywords

Barrett Esophagus; Esophageal Cancer; Primary care; General practice; Screening

Outcome Measures

Primary Outcomes (4)

• Positive Predictive Value (PPV) of the eNose for detecting confirmed BE

  PPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.

  16 weeks after breath test (eNose)

• Negative Predictive Value (NPV) of the eNose for detecting confirmed BE

  NPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.

  16 weeks after breath test (eNose)

• Sensitivity of the eNose for detecting confirmed BE

  Sensitivity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.

  16 weeks after breath test (eNose)

• Specificity of the eNose for detecting confirmed BE

  Specificity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.

  16 weeks after breath test (eNose)

Secondary Outcomes (13)

• Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS.

  Directly after breath test (eNose)

• Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS.

  Directly after uTNE

• Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS.

  Directly after conventional endoscopy

• Willingness to undergo repeat eNose procedure

  Directly after breath test (eNose)

• Willingness to undergo repeat uTNE procedure

  Directly after uTNE

Study Arms (1)

Breath test (eNose) followed by uTNE.

OTHER

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

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

Interventions

Breath test (eNose) followed by uTNE. DIAGNOSTIC_TEST

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

Breath test (eNose) followed by uTNE.

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Digestive Diseases Foundation: collaborator

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Peter D. Siersema, Prof.dr.

  Radboud University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a multi-site prospective cohort study in eight general practices. All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: April 20, 2021
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)