Barrett's esophagus
Conditions
Interventions
None listed
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: - Aged 18 years or older - Undergoing a clinically indicated (surveillance) endoscopy - Able to give signed informed consent 1. Patients with known BE (defined as =1 cm of columnar mucosa with histopathologic confirmation of intestinal metaplasia without dysplasia) 2. Individuals with GERD symptoms without BE (GERDQ-score =8 or the endoscopic presence of reflux esophagitis) 3. ‘Healthy’ controls without BE or GERD
Exclusion criteria
Exclusion criteria: - Patients with a history of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) - Prior surgical esophageal or gastric resection or prior ablative therapy - Patients who are unable to perform breathing maneuver needed for Aeonose-analysis of exhaled breath Withdrawal criteria after initial study inclusion: Patients can be withdrawn from the study if: - Incomplete upper endoscopy - Active H. Pylori infection - BE segment <1cm or no intestinal metaplasia in the esophagus - Intestinal metaplasia in the stomach
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the eNose for detecting BE with the diagnosis made by upper endoscopy as the reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Acceptance rates for breath testing - Patient acceptability of the eNose procedure - Technical or patient related problems obtaining a read-out from the Aeonose™ - Accuracy of the eNose with which it could distinguish patients with BE from patients with GERD - Reproducibility by repeated testing - Effect of PPI use on the accuracy of the eNose for detecting BE | — |
Contacts
Public ContactYonne Peters
Radboudumc
Outcome results
None listed