Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas

Study Overview
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Brief Summary
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This study is a clinical validation of our developed a computer-aided optical dignosis of advanced adenoma using non-magnified NBI image. This study is a randomized clinical trial comparing endoscopists' optical recognition of advanced adenoma for sending to histological examination with our computer-aided system. The hypothesis of the study is that the developed computer-aided system increases the percent of sending actual advanced adenoma Intelligence Assisted Optical Diagnosis of Advanced Adenomas

Detailed Description
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Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. However, it should be noted this policy could only be applied in diminutive polys considering high proposition of advanced adenomas in polyps more than 5 mm. In addition, optical diagnosis criteria of advanced adenomas have not been validated for finding advanced adenomas among adenoma polyps. If as many as advanced adenomas as possible could be differentiated from non-advanced adenomas and be further sent for histological examination, this policy could be generalized to small polyps. Considering this situation, the investigators tried to develop computer-aided optical dignosis of advanced adenoma using non-magnified NBI image with preliminary, satisfied results. In this study, the investigators next validate the investigators' developed computer-aided system for detecting advanced adenomas by comparing endoscopists' optical detection of advanced adenomas with or without the investigators' computer-aided system.

Official Title
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Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas

Conditions
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Advanced Adenoma

Intervention / Treatment
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* Device: AI system of optical detection of advanced adenomas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endoscopists with NBI experience Exclusion Criteria: Endoscopists without colonoscopy and NBI experience

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI assisted group<br>AI assisted endoscopist' optical detection of advanced adenomas among 100 images of polyps | Device: AI system of optical detection of advanced adenomas<br>* AI system of optical detection of advanced adenomas<br>|
| No Intervention: non-AI assisted group<br>Endoscopist' optical detection of advanced adenomas among 100 images of polyps using their experience of colonoscopy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of advanced adenomas for sending to histological examination | Proportion of advanced adenomas for sending to histological examination | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical diagnostic accuracy of non-advanced adenomas under high confidence | Optical diagnostic accuracy of non-advanced adenomas under high confidence | 1 day | 
| Proportion of high confidence optical diagnosis of polyps | Proportion of high confidence optical diagnosis of polyps | 1 day |