Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions

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

RECRUITING

Clinical Phase

NA

Total Enrollment

1460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2029-12-31

Brief Summary

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In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.

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Detailed Description

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The adherence of doctors to published surveillance guidelines for patients with gastric premalignant lesions varies greatly, and surveillance of patients is critical but time-consuming. In previous studies we developed an automatic surveillance (AS) system to accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.

Conditions

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Artificial Intelligence Surveillance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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With automatic surveillance system

Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time.

Group Type EXPERIMENTAL

AI based automatic surveillance (AS) system (ENDOANGEL-AS)

Intervention Type OTHER

An automatic surveillance (AS) system accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times.

With manual reminder

Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time.

Group Type EXPERIMENTAL

Manually remind the patients

Intervention Type OTHER

Medical staff remind patients to review manually.

Normal group

The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AI based automatic surveillance (AS) system (ENDOANGEL-AS)

An automatic surveillance (AS) system accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times.

Intervention Type OTHER

Manually remind the patients

Medical staff remind patients to review manually.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 18 years or older who undergo upper endoscopy.

Exclusion Criteria

* 1)No contact information or invalid contact information.
* 2\) The surveillance interval cannot be determined according to the surveillance guidelines, including no upper gastrointestinal pathology, therapeutic endoscopy or with history of previous gastrectomy, esophagectomy, or ESD, no dysplasia degrees, no biopsy sites, non-epithelial lesions, duodenal lesions, ulcer and so on.
* 3\) Needless for surveillance or others.
* 4\) High-grade intraepithelial neoplasia or cancer of the esophagus or stomach.
* 5\) Low-grade intraepithelial neoplasia of the esophagus and Barrett's esophagus.
* 6\) High-risk diseases or other special conditions for which the patient is deemed unsuitable for clinical trials by the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No