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Trial Title:
AI-assisted White Light Endoscopy to Identify the Kimura-Takemoto Classification of Atrophic Gastritis
NCT ID:
NCT05916014
Condition:
Atrophic Gastritis
Artificial Intelligence
Endoscopy
Conditions: Official terms:
Gastritis
Gastritis, Atrophic
Atrophy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Diagnostic Test: The diagnosis of Artificial Intelligence and endosopists
Description:
Endosopists and AI will assess the Kimura-Takemoto classification independently when the
patients is eligible.
Arm group label:
Chronic atrophic gastritis observed by white light endoscope
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.
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gastrology, QiLu Hospital, Shandong University
Address:
City:
Shangdong
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
yanqing Li, MD, PHD
Phone:
0531182169385
Email:
liyanqing@sdu.edu.cn
Start date:
June 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shandong University
Agency class:
Other
Collaborator:
Agency:
Linyi County People's Hospital,Dezhou,China
Agency class:
Other
Source:
Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05916014
