Gastroesophageal reflux disease (GERD) Barrett's Esophagus (BE) Esophageal Adenocarcinoma (EAC)
Conditions
Interventions
Device: Aeonose
An electronic nose device is an artificial olfactory system that analyses volatile organic compounds (VOCs) in exhaled breath. The AeonoseTM is a handheld device of 650 gram. A nose
Sponsors
Radboud University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Subjects, who are: - Aged 18 years or older. - Able to give signed informed consent. 1. Patients with known Barrett's Esophagus (BE), who are. - Diagnosed with a BE segment >1cm in maximal extent endoscopically (CxM1). - Histology showing evidence of intestinal metaplasia without presence of dysplasia. - Undergoing clinically indicated (surveillance) endoscopy. 2. Individuals with reflux symptoms without BE, who are. - Undergoing clinically indicated diagnostic endoscopy due to upper gastrointestinal symptoms (non-acute symptoms of heartburn, pain in the epigastric region or bloating, with the cause likely to be located in the upper gastrointestinal tract). - GerdQ self-assessment questionnaire score ¡Ý 8. 3. Healthy individuals without BE and without reflux symptoms, who are - Undergoing clinically indicated diagnostic endoscopy. - GerdQ self-assessment questionnaire score < 6.
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)) • Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation) or endoscopic mucosal resection. • Patients with history of esophageal or gastric resection or surgery which has changed the esophageal anatomy. •Patients who are unable to perform breathing maneuver needed for Aeonose-analysis of exhaled air
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ability to distinguish between patients with BE, healthy individuals, and patients with reflux symptoms by eNose in terms of sensitivity, specificity and accuracy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cross-validated accuracy with which the eNose can distinguish between patients with BE, healthy individuals and patients with reflux symptoms, defined as the percentage of correctly classified patients using the leave-some out method. - Acceptance rate of using the eNose | — |
Contacts
Public ContactYonne Peters
Department of Gastroenterology and Hepatology (455)
Outcome results
None listed