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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,200
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.
Expert endoscopists perform routine screening upper gastrointestinal endoscopy without CDSS's help.
Chuncheon Sacred Heart hospital
Chuncheon, Gangwon-do, South Korea
RECRUITINGGastric lesion detection rate
Gastric lesions (low or high grade dysplasia, early gastric cancer, or advanced gastric cancer) detection rate
Time frame: Baseline (gold standard; ground truth is expert endoscopists' lesion detection)
Lesion classification accuracy
Whether CDSS correctly diagnosed detected lesions or not
Time frame: Baseline (gold standard; ground truth is histologic diagnosis of detected lesions)
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