Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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 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 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Male or female aged 18 years or older who undergo upper endoscopy.
Exclusion Criteria:
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1)No contact information or invalid contact information.
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- 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.
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- Needless for surveillance or others.
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- High-grade intraepithelial neoplasia or cancer of the esophagus or stomach.
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- Low-grade intraepithelial neoplasia of the esophagus and Barrett's esophagus.
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- High-risk diseases or other special conditions for which the patient is deemed unsuitable for clinical trials by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renmin Hospital of Wuhan University | Wuhan | Hubei | China | 430060 |
| 2 | Shanghai Pudong Hospital | Shanghai | Shanghai | China | 201399 |
Sponsors and Collaborators
- Renmin Hospital of Wuhan University
- Shanghai Pudong Hospital
Investigators
- Principal Investigator: Honggang Yu, PhD, Renmin Hospital of Wuhan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EA-AS2023-01