No registrations found.
ID
Source
Brief title
Health condition
Barrett's esophagus, dysplasia, esophageal adenocarcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Summary
Rationale:
To detect dysplastic or early neoplastic lesions, endoscopic surveillance is recommended in patients with Barrett’s esophagus (BE). The number of patients experiencing discomfort of upper endoscopy is much larger than the number of patients that experience potential benefit of the procedure, as only a few will develop malignancy. Currently, a less burdensome, highly accurate surveillance method for BE is lacking. The aim of the study is to establish the accuracy with which the eNose can differentiate BE patients with dysplasia from BE patients without dysplasia.
Main objectives
- To assess whether it is possible to detect dysplastic or neoplastic lesions in patients with Barrett’s esophagus noninvasively by VOC breath recognition using an electronic nose device.
- To assess the acceptance rate of using the eNose device.
Study design:
The current study will be a multi-center cross-sectional, exploratory proof of principle study to explore whether an electronic nose device is able to distinguish BE patients with dysplasia from those without dysplasia by VOC analysis of patient breath samples.
Study population:
The study population consist of adult patients who are undergoing a clinically indicated surveillance upper endoscopy. Patients who are planned to undergo endoscopy will be asked to participate in this study. Subjects will be divided into two groups based on current diagnosis: (1) patients with known BE without dysplasia (n=25), (2) patients with BE and LGD (n=25), (3) and patients with BE and HGD or EAC (n=25).
Main study parameters / endpoints:
1. The ability to distinguish between BE patients with dysplastic or neoplastic lesions and patients with NDBE by eNose in terms of sensitivity, specificity and accuracy.
2. Cross-validated accuracy with which the eNose can differentiate 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.
3. Acceptance rate of using the eNose
Study objective
The eNose is able to differentiate between BE patients with dysplastic or neoplastic lesions and patients with NDBE
Study design
Each patient will be recruited for breath testing immediately before regular upper endoscopy and will provide a 5-minute continuous breath sample.
Intervention
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 clip will be used to prevent the entry of non-filtered air and patients will be instructed to enclose the mouthpiece with their mouth at all times. A measurement cycle lasts for about 15 minutes, of which 5 minutes of in-and exhalation by the patient takes place.
Yonne Peters
P.O. box 9101
Nijmegen 6500 HB
The Netherlands
+31615956464
y.peters@radboudumc.nl
Yonne Peters
P.O. box 9101
Nijmegen 6500 HB
The Netherlands
+31615956464
y.peters@radboudumc.nl
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6870 |
| NTR-old | NTR7048 |
| Other | CMO radboudumc : 2017-3543 |