Reddish depressive lesion in stomach
Conditions
Interventions
Magnified gastrointestinal endoscopy with NBI system
Normal white light gastrointestinal endoscopy
Sponsors
First Department of Internal Medicine, Sapporo Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who will have newly detected gastric depressed lesion, which needs to be biopsied for diagnosis, in upper gastrointestinal screening by regular endoscopy.
Exclusion criteria
Exclusion criteria: 1. Lesions already diagnosed before the study 2. Obvious carcinoma 3. Non-epithelial tumor 4. Lesions which cannot be biopsied (e.g. because recipients receive anti-platelet therapy) 5. Lesions which cannot be pathologically diagnosed (e.g. because specimen is too small to be diagnosed" 6. Lesions detected by trans-nasal upper gastrointestinal endoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the following outcomes of magnifying endoscopy with NBI compared with those of normal white light endoscopy, when we diagnose reddish depressive lesion in stomach using these devices. 1. Primary outcomes: 1) exact diagnostic rate (verified by pathological examination), 2) sensitivity, specificity, positive predictive value, and negative predictive value (for cancer diagnosis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Secondary outcomes: 1) to determine useful findings of magnifying endoscopy with NBI to discriminate gastric cancer from benign lesion, 2) to evaluate whether magnifying endoscopy with NBI needs extra time during examination, compared with normal white light endoscopy | — |
Countries
Japan
Contacts
Public ContactTokuma Tanuma
Sapporo Medical University School of Medicine First Dept. of Int. Med.
Outcome results
None listed