CDSS-assisted UGI Endoscopy vs. Routine Screening Endoscopy

Healthy Individual Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452473
• Other study ID #: AI RCT1
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: December 6, 2022

Study information

• Verified date: July 2022
• Source: Chuncheon Sacred Heart Hospital
• Contact: Chang Seok Bang, MD., PhD.
• Phone: +82332405000
• Email: csbang[@]hallym.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 6, 2022
• Est. primary completion date: August 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Individual

Intervention

Other:
• CDSS-assisted upper GI endoscopy
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.
• no intervention
Expert endoscopists perform routine screening upper gastrointestinal endoscopy without CDSS's help.

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart hospital	Chuncheon	Gangwon

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lesion classification accuracy	Whether CDSS correctly diagnosed detected lesions or not	Baseline (gold standard; ground truth is histologic diagnosis of detected lesions)