ETMI vs. standard video endoscopy for the detection of early neoplasia in patients with low-grade dysplasia in a Barrett's esophagus: a multi-center randomized cross-over controlled study
Recruiting
- Conditions
- Barrett's esophagus
- Registration Number
- NL-OMON20674
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
1. Barrett's esophagus patients with low-grade dyplasia comfirmed by two expert GI pathologists;
2. Written informed consent
Exclusion Criteria
1. Presence of active erosive esophagitis grade A according to the Los Angles classification of erosive esophagitis;
2. Presence of conditions precluding histological sampling of the esophagus (e.g. esophageal varices, coagulation disorders, anticoagulant therapy);
3. < 18 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of patients with early neoplasia detected with ETMI or SVE;<br>2. Number of lesions with early neoplasia detected with ETMI and SVE.
- Secondary Outcome Measures
Name Time Method 1. Number of early neoplastic lesions detected with AFI only;<br>2. Reduction of false positives findings after detailed NBI evaluation.