Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk.

NCT ID: NCT05459428

Last Updated: 2022-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-20

Study Completion Date

2024-06-30

Brief Summary

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Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies.

Detailed Description

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Globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies. The investigators aim to design the CGGIM scores to evaluate gastric cancer risk.

Conditions

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Intestinal Metaplasia of Gastric Mucosa Confocal Laser Endomicroscopy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Confocal laser endomicroscopy scoring of the extent of intestinal metaplasia

Get pictures and Videos from gastric antrum body and angle by confocal laser endomicroscopy in order to calculate the CGGIM score.

No interventions assigned to this group

Artificial intelligence scoring of the extent of intestinal metaplasia

Get pictures and Videos from gastric antrum body and angle by Artificial intelligence in order to calculate the CGGIM score.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients aged 40-80 years undergoing the confocal laser endomicroscopy 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice President of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD, PhD

Role: STUDY_CHAIR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, QiLu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, MD, PhD

Role: CONTACT

0531182169385

Rui Ji, MD, PhD

Role: CONTACT

18560086103

Facility Contacts

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Rui Ji, MD, PhD

Role: primary

18560086103

Other Identifiers

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2022-SDU-QILU-108

Identifier Type: -

Identifier Source: org_study_id

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