Barrett oesophagus, refluxoesophagitis, Barrett oesophagitis, oesophaguscarcinoom, intestinal metaplasia, high grade dysplasia
Conditions
Interventions
In this prospective multicenter study, BE surveillance patients and BE patients with HGD/EC will be included. Successively, the BE is inspected using WLE, AFI, NBI and pCLE. Biopsies will be obtained
Sponsors
To be determined
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 yrs; 2. Circumferential BE >2 cm; 3. Non-dysplastic BE or low-grade dysplasia (LGD) (i.e. surveillance) or high-grade dysplasia (HGD)/ early cancer (EC) (i.e. work-up); 4. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior surgical or endoscopic treatment of esophageal neoplasia; 2. Erosive esophagitis (> LA grade B); 3. Inability to obtain biopsies; 4. Contraindication for fluorescein injection; 5. Unable to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ENDPOINTS REAL-TIME IMAGING: 1. Correlation of real-time NBI vs. pCLE with histology; 2. Reduction of the false-positive rate of WLE+AFI with NBI vs. pCLE; ENDPOINTS MOLECULAR ANALYSIS: 1. Correlation of AFI directed biopsies and yield of molecular abnormalities compared to random biopsies; 2. Correlation of AFI patterns and molecular abnormalities in BE; 3. Show that AFI increases detection of molecular markers with greater sensitivity and specificity than EQMI detection of dysplasia. | — |
Secondary
| Measure | Time frame |
|---|---|
| ENDPOINTS VIDEO/STILL IMAGE EVALUATION: 1. Sensitivity and specificity for AFI-NBI vs. AFI-pCLE; 2. Accuracy of predicting presence/absence of HGD/EC with NBI vs. pCLE in a blinded manner; 3. Reduction of AFI FP lesions with NBI vs. pCLE; 4. Inter-observer variability in classifying lesions with NBI vs. pCLE, using kappa statistics. | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
Academic Medical Center Bldg. C2-210, Meibergdreef
Outcome results
None listed