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

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 Overview

• Status: Not yet recruiting
• Conditions: Artificial Intelligence; Surveillance
• Intervention / Treatment: Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS); Other: Manually remind the patients

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 Type: Interventional
• Enrollment (Estimated): 1460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Honggang Yu, PhD; Phone Number: 13871281899; Email: yuhonggang1969@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
      • Contact: Honggang Yu, PhD; Phone Number: 13871281899; Email: yuhonggang@whu.edu.cn
  • Shanghai
    • Shanghai, Shanghai, China, 201399
      • Shanghai Pudong Hospital
      • Contact: Wujun Xiong, Doctor; Phone Number: 13916617586; Email: xiongwujun@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normal group; The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.
Experimental: 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.	Other: 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.
Experimental: With manual reminder; 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; Medical staff remind patients to review manually.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Collaborators: Shanghai Pudong Hospital
• Investigators: Principal Investigator: Honggang Yu, PhD, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 9, 2023
• First Submitted That Met QC Criteria: September 9, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: surveillance rate; automatic surveillance
• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: EA-AS2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No