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

NCT05916014 | Recruiting

• 1 other identifier: 2022SDU-QILU-123
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrophic Gastritis; Artificial Intelligence; Endoscopy

Outcome Measures

Primary Outcomes (3)

• Accuracy of AI model to diagnose the Kimura-Takemoto classification

  Accuracy of AI model to diagnose the Kimura-Takemoto classification

  2 years

• Sensitivity of AI model to diagnose the Kimura-Takemoto classification

  Sensitivity of AI model to diagnose the Kimura-Takemoto classification

  2 years

• Specificity of AI model to diagnose the Kimura-Takemoto classification

  Specificity of AI model to diagnose the Kimura-Takemoto classification

  2 years

Secondary Outcomes (1)

• The MIOU value of AI model in semantic segmentation of endoscopic atrophy picture

  2 years

Study Arms (1)

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: Diagnostic Test: The diagnosis of Artificial Intelligence and endosopists

Interventions

Diagnostic Test: The diagnosis of Artificial Intelligence and endosopists DIAGNOSTIC_TEST

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

Chronic atrophic gastritis observed by white light endoscope

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria at Qilu Hospital,Shandong University,Linyi County People's Hospital will be enrolled into the study

You may qualify if:

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

You may not qualify if:

• patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric;
• disorders who cannot participate in gastroscopy;
• Patients with progressive gastric cancer;
• low quality pictures;
• patients with previous surgical procedures on the stomach or esophageal;
• patients who refuse to sign the informed consent form;

Sponsors & Collaborators

• Shandong University: lead
• Linyi County People's Hospital,Dezhou,China: collaborator

Study Sites (1)

Department of Gastrology, QiLu Hospital, Shandong University

Shangdong, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• yanqing li, MD,PHD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

yanqing Li, MD, PHD

CONTACT

0531182169385; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Qilu Hospital

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)