Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.

Detailed Description
-----------------
The accuracy of histologic prediction for the colorectal polyps with the use of narrow band imaging is evaluated between the test group with magnifying colonoscopy and the control group without magnifying colonoscopy.

Official Title
-----------------
A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps

Conditions
-----------------
Intestinal Polyps

Intervention / Treatment
-----------------
* Device: NBI with magnification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with colorectal polyps which are in need of EMR Exclusion Criteria: pregnancy, IBD, colorectal cancer, etc.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>histologic prediction only with the narrow band imaging (without magnification) | |
| Other: test group<br>histologic prediction with narrow band imaging plus magnification | Device: NBI with magnification<br>* After randomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. Two groups will be compared with each other.<br>* Other names: Narrow band image with magnification;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification | After radomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. After 1 week, confirmed pathologic diagnosis and predicted histologic diagnosis based on endoscopic observation are compared and its accuracy is evaluated. | After 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the endoscopic histologic prediction with NBI plus magnification | Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity. | 1 Week | 
| Specificity of the endoscopic histologic prediction with NBI plus magnification | Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of specificity. | 1 Week | 
| Positive predictive value of the endoscopic histologic prediction with NBI plus magnification | Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of positive predictive value. | 1 Week | 
| Negative predictive value of the endoscopic histologic prediction with NBI plus magnification | Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value. | 1 Week |