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

Not Applicable

Recruiting

• Conditions: Surveillance; Artificial Intelligence
• Interventions: Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS); Other: Manually remind the patients

• Registration Number: NCT06039917
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-09-09
• Study First Submitted QC: 2023-09-09
• Study Start: 2023-09-10
• Study First Posted: 2023-09-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1460

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With automatic surveillance system	AI based automatic surveillance (AS) system (ENDOANGEL-AS)	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.
With manual reminder	Manually remind the patients	Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time.

Primary Outcome Measures

Name	Time	Method
On-time Surveillance Rate	From enrollment to study completion, assessed up to 3 years.	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.

Secondary Outcome Measures

Name	Time	Method
lesion regression rate	From enrollment to study completion, assessed up to 3 years.	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.
Surveillance Rate	From enrollment to study completion, assessed up to 3 years.	The numerator is the number of patients with surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
The accuracy of classifying risk levels	1 day At the time of enrollment	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.
The incidence rate of early gastric cancer	From enrollment to study completion, assessed up to 3 years.	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.
The incidence rate of gastric cancer	From enrollment to study completion, assessed up to 3 years.	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.
The accuracy of identifying patients with gastric premalignant lesions	1 day At the time of enrollment	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.
The accuracy of assigning surveillance intervals	1 day At the time of enrollment	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.
Delayed Surveillance Rate	From enrollment to study completion, assessed up to 3 years.	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.
lesion persistence rate	From enrollment to study completion, assessed up to 3 years.	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.
Advance Surveillance Rate	From enrollment to study completion, assessed up to 3 years.	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.
lesion progression rate	From enrollment to study completion, assessed up to 3 years.	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.

Trial Locations

Locations (4)

Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus; 🇨🇳 Quanzhou, Fujian, China

The Eighth Hospital of Wuhan; 🇨🇳 Wuhan, Hubei, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Shanghai Pudong Hospital; 🇨🇳 Shanghai, Shanghai, China