Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia.
Phase 2
Completed
- Conditions
- Colorectal neoplasm
- Registration Number
- JPRN-UMIN000003740
- Lead Sponsor
- Osaka Medical Center for Cancer and Cardiovascular Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 550
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who had previously undergone histological examination. 2)Patients with open bleeding or symptoms suspected colonic stenosis. 3)Patients with inflammatory bowel disease, familial polyposis and known colon neoplasm. 4)Patients who are receiving anticoaglant medication or having bleeding tendency. 5)Patients with severe organ failure. 6)Patients without informed consent. 7)Patients who are regarded in-eligible by the doctor who participates in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Specificity of NBI-ME in accurate decision for low grade dysplasia.
- Secondary Outcome Measures
Name Time Method Procedure time (insertion and observation), Diagnostic ability (sensitivity, specificity and accuracy) for high grade dysplasia, low grade dysplasia and non-neoplastic lesion using NBI-nonME and NBI-ME, Accurate clinical decision rate (resect and discard, resect and send and leave it in situ) using NBI-nonME and NBI-ME. Diagnostic accuracy according to the lesion size (<5mm, >6mm). Adverse events.