Artificial Intelligence, Surveillance
Conditions
Keywords
surveillance rate, automatic surveillance
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.
Interventions
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.
Medical staff remind patients to review manually.
Sponsors
Shanghai Pudong Hospital
The Eighth Hospital of Wuhan
Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactHonggang Yu, PhD
Outcome results
None listed