ext generation optical coherence tomography for improved detection of early Barrett*s neoplasia
- Conditions
- Barrett's esophagusearly esophageal cancer10017990
- Registration Number
- NL-OMON47641
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
- Age > 18 years;
- Known BE, defined as columnar lined epithelium of the esophagus containing intestinal metaplasia upon biopsy, with or without dysplasia (low-grade or high-grade dysplasia or early adenocarcinoma);
- Signed informed consent.
- Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe;
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe;
- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe;
- Contraindications for ER and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices);
- Previously treated dysplasia by either ER and/or ablation therapy;
- Unable to provide signed informed consent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Per area and per patient analysis of diagnostic accuracy of both the VLE<br /><br>prediction score and the VLE computer algorithm.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Inter-observer agreement of the VLE prediction score<br /><br>- Identification of additional in-vivo clinical features predictive of early<br /><br>neoplasia<br /><br>- Time to analyse a complete VLE scan using the VLE prediction score;<br /><br>- Time to analyse a complete VLE scan using the computer algorithm.</p><br>