A clinical trial for evaluating diagnostic utility of magnified endoscopic examination with narrow band imaging (NBI) for reddish depressive lesion in stomach
Not Applicable
- Conditions
- Reddish depressive lesion in stomach
- Registration Number
- JPRN-UMIN000003408
- Lead Sponsor
- First Department of Internal Medicine, Sapporo Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 752
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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