Advanced imaging using Volumetric Laser Endomicroscopy (VLE) for improved detection of early Barrett's neoplasia.
Completed
- Conditions
- - Barrett's esophagus<br /><br />Dutch: Barrett slokdarm
- Registration Number
- NL-OMON27780
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
Pre-work:<br> Swager A. et al. Feasibility of laser marking in Barrett's esophagus with volumetric laser endomicroscopy: first-in-man pilot study. Gastrointest Endosc. 2017 Sep;86(3):464-472. doi: 10.1016/j.gie.2017.01.030.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Males or females aged ≥ 18 years
- Known BE, defined as columnar lined epithelium of the esophagus containing intestinal metaplasia upon biopsy.
Exclusion Criteria
- Patients for who use of the NvisionVLE Imaging System would be in conflict with the Instructions For Use (IFU).
- Presence of an esophageal mass that precludes full distension of the balloon from the NVisionVLE Marking Probe
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Per area and per patient analysis of diagnostic accuracy of both VLE experts and the VLE computer algorithm.
- Secondary Outcome Measures
Name Time Method - Inter-observer agreement of the VLE experts (Cohen's kappa coefficient)<br /><br>- Identification of additional in-vivo clinical features, predictive of early neoplasia<br /><br>- Time (s) to analyse a complete VLE scan; <br /><br>- Experts vs. computer algorithm <br>- Level of confidence<br>- VLE experience correlated to diagnostic accuracy<br>- Diagnostic accuracy of BE neoplasia using single frames versus multi-frame regions of interest versus full scan analysis<br>