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RecruitingNCT05916014Updated Apr 12, 2024

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

An observational study in Atrophic Gastritis, Artificial Intelligence and Endoscopy, sponsored by Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Shandong University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Atrophic Gastritis
  • Artificial Intelligence
  • Endoscopy
03

In context

Gastritis

196 studies on the registry are indexed under Gastritis; 42 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 400 across 79 observational studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

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;
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 testDiagnostic Test: The diagnosis of Artificial Intelligence and endosopists

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

06

What researchers measure

Primary outcomes

  1. Accuracy of AI model to diagnose the Kimura-Takemoto classification

    Accuracy of AI model to diagnose the Kimura-Takemoto classification

    Time frame: 2 years

  2. Sensitivity of AI model to diagnose the Kimura-Takemoto classification

    Sensitivity of AI model to diagnose the Kimura-Takemoto classification

    Time frame: 2 years

  3. Specificity of AI model to diagnose the Kimura-Takemoto classification

    Specificity of AI model to diagnose the Kimura-Takemoto classification

    Time frame: 2 years

Secondary outcomes

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

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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Department of Gastrology, QiLu Hospital, Shandong University
    Shangdong, Shandong 250012, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05916014
Lead sponsor
Shandong University
Collaborators
Linyi County People's Hospital,Dezhou,China
Responsible party
Yanqing Li (Vice President of Qilu Hospital, Shandong University) — Principal investigator
First posted
Jun 23, 2023
Start date
Jun 1, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Apr 12, 2024

Study contacts

yanqing Li, MD, PHD
Contact
liyanqing@sdu.edu.cn
0531182169385
yanqing li, MD,PHD
study chair · Qilu Hospital, Shandong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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