CDSS-assisted UGI Endoscopy vs. Routine Screening Endoscopy

Chuncheon Sacred Heart Hospital

Status: Enrolling

Conditions: Healthy Individual

Treatments: Other: no intervention; Other: CDSS-assisted upper GI endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05452473

AI RCT1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups, including a placebo group

CDSS-assisted screening endoscopy

Experimental group

Description:

Participants will be tested for CDSS-assisted screening upper gastrointestinal endoscopy

Treatment:

Other: CDSS-assisted upper GI endoscopy

Conventional routine screening endoscopy

Placebo Comparator group

Description:

Participants will be tested for Conventional routine screening upper gastrointestinal endoscopy

Treatment:

Other: no intervention