GI epithelial lesions
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with suspected digestive disease such as a gastric carcinoma, gastric adenoma, colon carcinoma, colon adenoma.
Exclusion criteria
Exclusion criteria: 1) Patients not indicated for normal endoscopy 2) History of allergy to fluorescein dye 3) Subjects with a severe comorbidity such as a diabetic disease, cardiovascular, neurologic dysfunction, cirrhosis of the liver, pheochromocytoma and pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The procedural success rate of the visualization of the structure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Comparing CLE findings with normal endoscopic findings, magnifying-endoscopic findings and pathological findings 2) Differential diagnosis 3) Image quality assessment. The evaluation criteria are divided into three(poor, almost invisible tissue structure; mild, visible tissue structure with too dark vision; good, clearly visible tissue structure). 4) Adverse events | — |
Countries
Japan
Contacts
The Jikei University School of Medicine Department of Endoscopy