Health TrialsbyHealthPanel

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

ConditionsArtificial IntelligenceSurveillance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenmin Hospital of Wuhan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged 18 years or older who undergo upper endoscopy.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI based automatic surveillance (AS) system (ENDOANGEL-AS)

    Other intervention

    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.

  • Manually remind the patients

    Other intervention

    Medical staff remind patients to review manually.

Treatment groups

1,460 Participants
are divided into 3 treatment groups
Group A: With automatic surveillance systemExperimental treatment 1 intervention
Group B: With manual reminderExperimental treatment 1 intervention
Group C: Normal groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to study completion, assessed up to 3 years.

Secondary outcomes

1

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.

Time frame
From enrollment to study completion, assessed up to 3 years.
2

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.

Time frame
From enrollment to study completion, assessed up to 3 years.
3

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.

Time frame
From enrollment to study completion, assessed up to 3 years.
4

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.

Time frame
1 day At the time of enrollment

Other outcomes

Sponsors and contacts

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Renmin Hospital of Wuhan University

Lead sponsor

Shanghai Pudong Hospital

Collaborator

The Eighth Hospital of Wuhan

Collaborator

Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus

Collaborator

Source ClinicalTrials.gov
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