Validation the Artificial Intelligence System for Automatic Evaluation of the Extent of Intestinal Metaplasia

Validation the Artificial Intelligence System for Automatic Evaluation of the Extent of

The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. But its clinical application is limited for at least biopsy samples. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. The investigators designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.

Study Overview

• Status: Completed
• Conditions: Artificial Intelligence; Endoscopy; Intestinal Metaplasia of Gastric Mucosa
• Intervention / Treatment: Diagnostic test: The diagnosis of Artificial Intelligence and endosopists

Detailed Description

Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. However, its need to take at least 4 biopsies is not clinically feasible. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. An EGGIM score of 5 was the best cut off value for identifying OLGIM stage III/IV patients. The investigators have designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.

• Study Type: Observational
• Enrollment (Actual): 1080

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Department of Gastrology, QiLu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• 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 will be enrolled into the study

Description

Inclusion Criteria:

• patients aged 40-75 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 with contraindications to biopsy
• patients who refuse to sign the informed consent form

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastric intestinal metaplasia observed by IEE; Get pictures from gastric antrum body and angle by image-enhanced endoscopy in order to calculate the EGGIM score.	Diagnostic test: The diagnosis of Artificial Intelligence and endosopists; Endosopists and AI will assess the EGGIM score independently when the patients is eligible. In addition, they can not see the OLGIM score of the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of AI model to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score	A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of experienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score	A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.	2 years
Accuracy of inexperienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score	A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.	2 years
Inter-observer agreement among experienced endoscopists in identifying the EGGIM scores	A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.	2 years
Inter-observer agreement among inexperienced endoscopists in identifying the EGGIM scores	A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, > 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.	2 years

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Study Chair: yanqing Li, MD, PHD, Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia
• Other Study ID Numbers: 2022SDU-QILU-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No