CDSS-assisted UGI Endoscopy vs. Routine Screening Endoscopy

Study Overview
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Brief Summary
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This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups.

Detailed Description
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Artificial intelligence has been adopted in the field of gastrointestinal endoscopy. Investigators previously established deep-learning models to predict the histology and invasion depth of gastric lesions using endoscopic stillcut images. However, clinical benefit of this model has not been evaluated. This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients who visited Chuncheon Sacred Heart hospital will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups. Expert endoscopists will conduct this randomized study.

Official Title
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Clinical Benefit in the CDSS-assisted Screening Upper Gastrointestinal Endoscopy vs. Routine Screening Endoscopy

Conditions
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Healthy Individual

Intervention / Treatment
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* Other: CDSS-assisted upper GI endoscopy
* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who visited for routine screening upper gastrointestinal endoscopy Exclusion Criteria: Participants who refuse to participate in this study Participants who showed paradoxical reaction prohibiting routine examination

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDSS-assisted screening endoscopy<br>Participants will be tested for CDSS-assisted screening upper gastrointestinal endoscopy | Other: CDSS-assisted upper GI endoscopy<br>* Expert endoscopists perform screening upper gastrointestinal endoscopy while looking at the monitor (CDSS system: automatic detection or lesion classification function) and listening to the sound of the monitor next to the original endoscopy monitor system.<br>|
| Placebo Comparator: Conventional routine screening endoscopy<br>Participants will be tested for Conventional routine screening upper gastrointestinal endoscopy | Other: no intervention<br>* Expert endoscopists perform routine screening upper gastrointestinal endoscopy without CDSS's help.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric lesion detection rate | Gastric lesions (low or high grade dysplasia, early gastric cancer, or advanced gastric cancer) detection rate | Baseline (gold standard; ground truth is expert endoscopists' lesion detection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion classification accuracy | Whether CDSS correctly diagnosed detected lesions or not | Baseline (gold standard; ground truth is histologic diagnosis of detected lesions) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Convolutional neural network, Deep learning, Endoscopy, Gastric neoplasms