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

Wuhan University

Status: Enrolling

Conditions: Surveillance; Artificial Intelligence

Treatments: Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS); Other: Manually remind the patients

Study type: Interventional

Funder types: Other

Identifiers

NCT06039917

EA-AS2023-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,460 participants in 3 patient groups

With automatic surveillance system

Experimental group

Description:

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.

Treatment:

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

With manual reminder

Experimental group

Description:

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

Treatment:

Other: Manually remind the patients

Normal group

No Intervention group

Description:

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