A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients with Barrett*s Dysplasia or Intramucosal Adenocarcinoma
Completed
- Conditions
- 1) Barrett's oesophagus2) early oesophageal cancer1001799010017991
- Registration Number
- NL-OMON40469
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- Males and females over the age of 18 years. - Patients with either suspected or confirmed Barrett*s-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR. - Patients with non-dysplastic Barrett*s oesophagus - Eligible for endoscopic resection of Barrett mucosa. - Ability to provide written, informed consent.
Exclusion Criteria
- patients with a condition precluding full distension of the N-Vision balloon, such as strictures or a mass - inability to obtain biopsies and/or EMR (e.g. due to antocoagulation therapie, coagulation disorder, varices) - eosophillic oesophagitis - oesophagitis > LA grade A - pregnancy - unable to provide signed informed consent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the correlation of features seen on VLE images to<br /><br>those seen on histopathology from mucosal resection specimens.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint will be the following: The creation of an image atlas,<br /><br>which will be used to determine the intra and inter observer agreement on VLE<br /><br>images in correlation with histopathology, resulting in refinement of the<br /><br>existing VLE image interpretation criteria and the validation of the VLE<br /><br>classification. </p><br>