EQMI-trial: Endoscopische Quad-Modal Imaging en moleculaire eindpunten ter opsporing van vroege neoplasie in Barrett oesophagus.
- Conditions
- Barrett oesophagus, refluxoesophagitis, Barrett oesophagitis, oesophaguscarcinoom, intestinal metaplasia, high grade dysplasia
- Registration Number
- NL-OMON21510
- Lead Sponsor
- To be determined
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Age >18 yrs;
2. Circumferential BE >2 cm;
Exclusion Criteria
1. Prior surgical or endoscopic treatment of esophageal neoplasia;
2. Erosive esophagitis (> LA grade B);
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ENDPOINTS REAL-TIME IMAGING:<br /> <br>1. Correlation of real-time NBI vs. pCLE with histology; <br /><br>2. Reduction of the false-positive rate of WLE+AFI with NBI vs. pCLE;<br /><br><br /><br>ENDPOINTS MOLECULAR ANALYSIS: <br /><br>1. Correlation of AFI directed biopsies and yield of molecular abnormalities compared to random biopsies; <br /><br>2. Correlation of AFI patterns and molecular abnormalities in BE; <br /><br>3. Show that AFI increases detection of molecular markers with greater sensitivity and specificity than EQMI detection of dysplasia.<br>
- Secondary Outcome Measures
Name Time Method ENDPOINTS VIDEO/STILL IMAGE EVALUATION: <br /><br>1. Sensitivity and specificity for AFI-NBI vs. AFI-pCLE; <br /><br>2. Accuracy of predicting presence/absence of HGD/EC with NBI vs. pCLE in a blinded manner; <br /><br>3. Reduction of AFI FP lesions with NBI vs. pCLE; <br /><br>4. Inter-observer variability in classifying lesions with NBI vs. pCLE, using kappa statistics.