Barrett'
Conditions
Interventions
None listed
Sponsors
Shinshu University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be aged 18 or older at enrollment. 2. Endoscopic examinations are conducted following ethics committee approval at each institution. 3. NBI magnifying endoscopy using a high-definition system (EVIS LUCERA or X1 light source and H260Z, H290Z, HQ290, XZ1200, or EZ1500 scopes with A8 or B8 settings) is performed for: i. Screening/surveillance of Barrett's esophagus (Prague M1 or higher). ii. Detailed examination before/during treatment for superficial Barrett's esophageal cancer. 4. Biopsy for distinguishing neoplastic or non-neoplastic lesions or endoscopic resection for treatment is conducted, allowing point by point comparison of images and pathology. 5. High-quality NBI magnified images (clear, focused, mucus, blood-free) of the evaluation site are preserved. 6. Captured images include: i. Low magnification: Diagnosing mucosal structure (not vascular). For Dual Focus devices, images in Dual Focus mode are used. ii. High magnification: Diagnosing vascular structure at full or near-full zoom. For Dual Focus devices, Dual Focus plus 1.4x zoom images are used. iii. (Biopsy cases only) Images showing the magnified observation area matches the biopsy site. 7. Tumors must be flat lesions (0-IIa, IIb, IIc). Polypoid elevated lesions (0-I) and ulcerative lesions (0-III), which lack identifiable mucosal or vascular patterns, are excluded.
Exclusion criteria
Exclusion criteria: 1. A history of chemotherapy or radiotherapy for esophageal squamous cell carcinoma. 2. Coexisting psychiatric disorders or mental symptoms that are deemed to make participation in the study difficult. 3. The investigator judges that enrollment in this study is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity for diagnosing neoplastic and non-neoplastic (dysplastic and non-dysplastic) lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy (specificity, accuracy, positive predictive value, negative predictive value) 2. Diagnostic reproducibility (inter- and intra-observer agreement) 3. Diagnostic accuracy and reproducibility stratified by confidence levels (low or high) | — |
Countries
Japan
Contacts
Public ContactYugo Iwaya
Shinshu University, School of Medicine Department of Medicine, Division of Gastroenterology and Hepatology
Outcome results
None listed