Prospective evaluation of autofluoroscence imaging endoscopy for screening of squamous mucosal high-grade neoplasia in the esophagus
Phase 2
- Conditions
- Esophageal neoplasia
- Registration Number
- JPRN-UMIN000002148
- 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
- 380
Inclusion Criteria
Not provided
Exclusion Criteria
Patients were excluded if they had previously undergone an operation, chemotherapy or radiotherapy for esophageal cancer, or had undergone chromoendoscopy with iodine staining within 6 months or allergic to iodine solution.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome variable in this study was the sensitivity of AFI on a per lesion basis.
- Secondary Outcome Measures
Name Time Method (1) The positive predictive value (PPV) of NBI in a per lesion basis; (2) the sensitivity, specificity, PPV, negative predictive value (NPV) and accuracy of AFI in a per patient basis. (3) The differences in sensitivities, specificities, NPVs, PPVs and accuracy with regard to study periods, endoscopists, lesions' size and HGIN or invasive cancer.