Barrett's esophagus, dysplasia, esophageal adenocarcinoma
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/have: - Aged 18 years or older. - Able to give signed informed consent. - Diagnosed with a BE segment >1cm in maximal extent endoscopically (C1Mx) - Histology showing evidence of intestinal metaplasia 1. Patients with known BE without dysplasia, who are/have: - Histology showing no evidence of dysplasia. - Undergoing clinically indicated surveillance endoscopy. 2. Patients with known BE, with a diagnosis of LGD, who are/have: - Histology showing evidence of low grade dysplasia. - Undergoing clinically indicated diagnostic endoscopy or had an endoscopy in the last 3 months. Version 1.1,29-6-2017 6 3. Patients with known BE, with a diagnosis of HGD or EAC, who are/have: - Histology showing evidence of high grade dysplasia or esophageal adenocarcinoma. - Undergoing clinically indicated diagnostic or therapeutic endoscopy or had an endoscopy showing HGD/EAC in the last 3 months.
Exclusion criteria
Exclusion criteria: - Patients with a history of any type of malignancy except for esophageal adenocarcinoma and non-melanoma skin cancer. - Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation) or endoscopic mucosal resection. - Patient with current history of eosinophilic esophagitis, infectious esophagitis, achalasia, esophagitis according to the Los Angeles classification (gr. A-D) or uninvestigated dysphagia. - Patients with history of known varices or cirrhosis. - Patients with history of esophageal or gastric resection or surgery which has changed the esophageal anatomy. - Patients with a history of esophageal squamous dysplasia. - Antibiotic use within the last 2 months before eNose procedure. - Infection of the oral cavity. - Patients with H. Pylori infection. - Patients who are unable to perform breathing manouevre needed for eNose-analysis of exhaled air.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ability to differentiate between BE patients with dysplastic or neoplastic lesions and patients with NDBE by eNose in terms of sensitivity, specificity and accuracy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cross-validated accuracy with which the eNose can distinguish between BE patients with dysplastic or neoplastic lesions and patients with NDBE, 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