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The aims of this research are to validate and develop of therapeutic strategies for patients with colorectal lesions in real time through pCLE(probe-based confocal laser endomicroscopy). Endomicroscopy is a technique for obtaining histology-like images from inside the human body in real-time. Total objections are 311 patients.
Specific research topics are as below.
The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions Check diagnostic agreement of technical phrases which are derived, the matching degree between observers, and will develope a new classification method based on this.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endo group | Experimental | colon polyp, early colon cancer, colorectal submucosal tumor, ileocecal ulcers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probe-based confocal laser endomicroscopy | Procedure | After shooting 10% fluorescein sodium in,2.5-5 .0 ml to the object with colorectal disease, the lesion will observed and evaluated with pCLE in real-time and also stored the inspection images. Then, determines the treatment plan to determine which is applied currently in clinical, Sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions Based on the inspection image stored, using Delphi approach tests, two or more are discussed, to derive a significant technical phrases. Check diagnostic agreement of technical phrases which are derived, the matching degree between observers, and developed a new classification method based on this. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of pCLE diagnosis | The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of pCLE diagnosis | The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions. | 2 weeks |
| Accuracy of pCLE diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae Il Kim, MD, PhD | Contact | 82-2-2228-1965 | taeilkim@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Recruiting | Seoul | 120-752 | South Korea |
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The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions. |
| 2 weeks |
| amphoteric predict of pCLE diagnosis | The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions. | 2 weeks |