Artificial Intelligence-assisted Confocal Laser Endomicroscopy Identification of Intestinal Metaplasia Severity

NCT05462743 | Unknown

• 1 other identifier: 2022-SDU-QILU-122
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the Correa cascade is a widely accepted model of gastric carcinogenesis. Intestinal metaplasia is a high risk factor for gastric cancer. According to Sydney criteria, mild intestinal metaplasia was not associated with gastric cancer, while moderate to severe intestinal metaplasia was strongly associated with the development of gastric cancer. Because intestinal metaplasia is distributed in various forms, the use of white light endoscopy lacks specificity, and the consistency with histopathological diagnosis is poor; Pathological biopsy is still needed to make a diagnosis. At present, national guidelines suggest that OLGIM score should be used to evaluate the risk of gastric cancer, and patients with OLGIM grade III/IV should be monitored by close gastroscopy. However, it requires at least four biopsies, which is clinically infeasible. Confocal laser endomicroscopy allows real-time observation of living tissue, comparable to pathological findings.

Conditions

Intestinal Metaplasia; Artificial Intelligence; Confocal Laser Endomicroscopy

Outcome Measures

Primary Outcomes (3)

• Accuracy of AI model in assessing degree of intestinal metaplasia

  Pathological biopsy results were used as the gold standard to assess the accuracy of the AI model in diagnosing the degree of intestinal metaplasia at the biopsy site

  2 years

• Sensitivity of AI model to assess degree of intestinal metaplasia

  The sensitivity of the AI model to diagnose the degree of intestinal metaplasia at the biopsy site was assessed using pathological biopsy results as the gold standard

  2 years

• Specificity of AI model to assess degree of intestinal metaplasia

  Pathological biopsy results were used as the gold standard to assess the specificity of the AI model in diagnosing the degree of intestinal metaplasia at the biopsy site

  2 years

Study Arms (2)

group for training the algorithm

This group of images is used for training the algorithm of the artifical intelligence

group for testing the algorithm

This group of images is used for testing the algorithm of the artifical intelligence

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who receive the upper gastrointestinal tract pCLE examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study.

You may qualify if:

• Patients aged 18-80 years undergoing confocal gastroscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250001, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

When a gastric mucosal leison is found using white light endoscopy, endoscopist will observe this lesion using pCLE and then take biopsy for histology examination.

Study Officials

• Yanqing Li

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li

CONTACT

053182169385; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Qilu Hospital

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 18, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

CN (1)