A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients with Barrett’s Dysplasia or Intramucosal Adenocarcinoma
Recruiting
- Conditions
- Barrett's esophagus early neoplasiaadvanced imagingBarrett slokdarmvroege neoplasie
- Registration Number
- NL-OMON29133
- Lead Sponsor
- AMC Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
1. Males and females over the age of 18 years;
2. Patients with either suspected or confirmed Barrett’s-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR;
Exclusion Criteria
1. Patients with a condition precluding full distension of the N-Vision balloon, such as strictures or a mass;
2. Inability to obtain biopsies and/or EMR (e.g. due to antocoagulation therapie, coagulation disorder, varices);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be the correlation of features seen on VLE images to those seen on histopathology from mucosal resection specimens.
- Secondary Outcome Measures
Name Time Method The secondary endpoint will be the following: The creation of an image atlas, which will be used to determine the intra and inter observer agreement on VLE images in correlation with histopathology, resulting in refinement of the existing VLE image interpretation criteria and the validation of the VLE classification.