Automatic Evaluation of the Extent of Intestinal Metaplasia With Artificial Intelligence

• Conditions: Endoscopy; Artificial Intelligence; Intestinal Metaplasia of Gastric Mucosa

• Registration Number: NCT05459610
• Lead Sponsor: Shandong University

Brief Summary

Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. The endoscopic grading system (EGGIM), a new endoscopic risk scoring system for GC, have been shown to accurately identify a wide range of patients with GIM. However, the high diagnostic accuracy of GIM using IEE and EGGIM assessments performed all require much experience, which limits the application of EGGIM. The investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores.

Detailed Description

Globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. Gastric intestinal metaplasia (GIM) is an intermediate precancerous gastric lesion in the gastric cancer cascade. Studies have shown that the 5-year cumulative incidence of gastric cancer in IM patients ranges from 5.3% to 9.8% . With technical advance of image-enhanced endoscopy (IEE), studies have demonstrated IEE has high accuracy for diagnosis of GIM. The endoscopic grading system (EGGIM), a new endoscopic risk scoring system for GC, have been shown to accurately identify a wide range of patients with GIM. However, The high diagnostic accuracy of GIM using IEE and EGGIM assessments performed all require much experience, which limits the application of EGGIM. The investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores.

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-01
• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• patients aged 18-80 years who undergo the IEE examination

Exclusion Criteria

• patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
• patients with previous surgical procedures on the stomach
• patients who refuse to sign the informed consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture	2 years	The sensitivity of AI model to assess the degree of intestinal metaplasia in an
The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture	2 years	The specificity of AI model to assess the degree of intestinal metaplasia in an endoscopic picture
The accuracy of AI model to assess the degree of intestinal metaplasia in an endoscopic picture	2 years	The accuracy of AI model to assess the degree of intestinal metaplasia in an endoscopic picture

Secondary Outcome Measures

Name	Time	Method
Accuracy of the experienced endoscopists to assess the degree of intestinal metaplasia	2 years	Accuracy of the experienced endoscopists to assess the degree of intestinal metaplasia in an endoscopic picture
Accuracy of the inexperienced endoscopists to assess the degree of intestinal metaplasia	2 years	Accuracy of the inexperienced endoscopists to assess the degree of intestinal metaplasia in an endoscopic picture
Inter-observer agreement among experienced endoscopists in identifying the degree of intestinal metaplasia	2 years	Inter-observer agreement among experienced endoscopists in identifying the degree of intestinal metaplasia in an endoscopic picture
Inter-observer agreement among inexperienced endoscopists in identifying degree of intestinal metaplasia	2 years	Inter-observer agreement among inexperienced endoscopists in identifying degree of intestinal metaplasia in an endoscopic picture

Trial Locations

Locations (1)

Department of Gastrology, QiLu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China