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

Study Overview
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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.

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.

Official Title
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Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions

Conditions
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Artificial Intelligence, Surveillance

Intervention / Treatment
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* Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)
* Other: Manually remind the patients


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With automatic surveillance system<br>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. | Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)<br>* 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.<br>|
| Experimental: With manual reminder<br>Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time. | Other: Manually remind the patients<br>* Medical staff remind patients to review manually.<br>|
| No Intervention: Normal group<br>The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-time Surveillance Rate | The numerator is the number of patients with on-time surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance. | From enrollment to study completion, assessed up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surveillance Rate | The numerator is the number of patients with surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| Advance Surveillance Rate | The numerator is the number of patients with surveillance in advance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| Delayed Surveillance Rate | The numerator is the number of patients with delayed surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| The accuracy of identifying patients with gastric premalignant lesions | The numerator is the number of patients correctly identified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions. | 1 day At the time of enrollment | 
| The accuracy of classifying risk levels | The numerator is the number of patients correctly classified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions. | 1 day At the time of enrollment | 
| The accuracy of assigning surveillance intervals | The numerator is the number of patients correctly assigned by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions. | 1 day At the time of enrollment | 
| lesion progression rate | The numerator is the number of patients with lesion progression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| lesion persistence rate | The numerator is the number of patients with lesion persistence, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| lesion regression rate | The numerator is the number of patients with lesion regression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| The incidence rate of early gastric cancer | The numerator is the number of patients with early gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| The incidence rate of gastric cancer | The numerator is the number of patients with gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance. | From enrollment to study completion, assessed up to 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surveillance rate, automatic surveillance