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

Artificial Intelligence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464108
• Other study ID #: 2022SDU-QILU-111
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2022
• Source: Shandong University
• Contact: yanqing Li, MD, PHD
• Phone: 0531182169385
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Artificial Intelligence
• Endoscopy
• Intestinal Metaplasia of Gastric Mucosa
• Metaplasia

Intervention

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.

Locations

Country	Name	City	State
China	Department of Gastrology, QiLu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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