CDSS-assisted UGI Endoscopy vs. Routine Screening Endoscopy

NCT05452473 | Unknown

• 1 other identifier: AI RCT1
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Individual

Keywords

Convolutional neural network; Deep learning; Endoscopy; Gastric neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lesion classification accuracy

  Baseline (gold standard; ground truth is histologic diagnosis of detected lesions)

Study Arms (2)

CDSS-assisted screening endoscopy

EXPERIMENTAL

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

Other: CDSS-assisted upper GI endoscopy

Conventional routine screening endoscopy

PLACEBO COMPARATOR

Participants will be tested for Conventional routine screening upper gastrointestinal endoscopy

Other: no intervention

Interventions

CDSS-assisted upper GI endoscopy OTHER

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.

CDSS-assisted screening endoscopy

no intervention OTHER

Expert endoscopists perform routine screening upper gastrointestinal endoscopy without CDSS's help.

Conventional routine screening endoscopy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who visited for routine screening upper gastrointestinal endoscopy

You may not qualify if:

• Participants who refuse to participate in this study
• Participants who showed paradoxical reaction prohibiting routine examination

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, 24253, South Korea

RECRUITING

Related Publications (1)

• Gong EJ, Bang CS, Lee JJ, Baik GH, Lim H, Jeong JH, Choi SW, Cho J, Kim DY, Lee KB, Shin SI, Sigmund D, Moon BI, Park SC, Lee SH, Bang KB, Son DS. Deep learning-based clinical decision support system for gastric neoplasms in real-time endoscopy: development and validation study. Endoscopy. 2023 Aug;55(8):701-708. doi: 10.1055/a-2031-0691. Epub 2023 Feb 8.

  PMID: 36754065 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Chang Seok Bang, MD, PhD

  Hallym University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Seok Bang, MD., PhD.

CONTACT

+82332405000; csbang@hallym.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: July 6, 2022
• Primary Completion: August 6, 2022
• Study Completion: December 6, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

KR (1)