AI-assisted White Light Endoscopy to Identify the Kimura-Takemoto Classification of Atrophic Gastritis

NCT ID: NCT05916014

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Grading endoscopic atrophy according to the Kimura-Takemoto classification can assess the risk of gastric neoplasia development. However, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. Therefore, this study aims to develop an AI model to identify the Kimura-Takemoto classification.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Grading endoscopic atrophy according to the Kimura-Takemoto classification can assess the risk of gastric neoplasia development. The higher the score, the more severe the degree of atrophic gastritis. However, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. Therefore, this study aims to develop an AI model to identify the Kimura-Takemoto classification of atrophic gastritis to achieve gastric cancer risk assessment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrophic Gastritis Artificial Intelligence Endoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chronic atrophic gastritis observed by white light endoscope

Get pictures from gastric antrum,gastric angle,lesser curvature of gastric body, cardia, gastric fundus, greater curvature of gastric body by white light endoscope

Diagnostic Test: The diagnosis of Artificial Intelligence and endosopists

Intervention Type DIAGNOSTIC_TEST

Endosopists and AI will assess the Kimura-Takemoto classification independently when the patients is eligible.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diagnostic Test: The diagnosis of Artificial Intelligence and endosopists

Endosopists and AI will assess the Kimura-Takemoto classification independently when the patients is eligible.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients aged 18-80 years who undergo the white light endoscope examination Informed consent form provided by the patient.

Exclusion Criteria

1. patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric;
2. disorders who cannot participate in gastroscopy;
3. Patients with progressive gastric cancer;
4. low quality pictures;
5. patients with previous surgical procedures on the stomach or esophageal;
6. patients who refuse to sign the informed consent form;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Linyi County People's Hospital,Dezhou,China

UNKNOWN

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yanqing Li

Vice President of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

yanqing li, MD,PHD

Role: STUDY_CHAIR

Qilu Hospital, Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Gastrology, QiLu Hospital, Shandong University

Shangdong, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

yanqing Li, MD, PHD

Role: CONTACT

0531182169385

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

yanqing Li, MD, PHD

Role: primary

0531182169385

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022SDU-QILU-123

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.