Miss Rate of Gastric Neoplasms Under Computer-aided Endoscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorThe University of Hong Kong
About this trial
This prospective randomized trial compares AI-assisted upper gastrointestinal endoscopy with high definition upper gastrointestinal endoscopy in term of missed rate of gastric neoplasm. The investigators hypothesize the miss rate of high definition upper gastrointestinal endoscopy is higher than AI-assisted upper gastrointestinal endoscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 40 or older
Scheduled for elective upper endoscopy
Disqualifiers
Pregnant women,
Inability to provide written informed consent
Prior gastrectomy, and
Patients deemed unsuitable or high-risk for endoscopy with severe comorbid illnesses
Trial design
Design model
Crossover
Treatments tested in this trial
AI-assisted upper gastrointestinal endoscopy
DeviceAI-assisted upper gastrointestinal endoscopy
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: AI-HD groupExperimental treatment 1 intervention
Group B: HD-AI groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gastric neoplasia miss rate
the number of newly detected gastric neoplasia in the second examination divided by the total number of gastric neoplasia detected in both examinations for each patient.
Time frame
during the interventionSecondary outcomes
1
Gastric neoplasia detection rate
The proportion of patients with one or more gastric neoplasms detected in the first examination
Time frame
during the intervention2
The biopsy rate
The proportion of patients who had a biopsy sample taken as a result of the first examination
Time frame
during the intervention3
The number of gastric neoplasms per patient
The total number of gastric neoplasms detected in the first examination divided by the total number of patients
Time frame
during the intervention4
The miss rate of patients with gastric neoplasms
The number of patients with a newly detected gastric neoplasm in the second examination divided by the total number of patients with gastric neoplasms detected in both examinations
Time frame
during the interventionSponsors and contacts
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Source ClinicalTrials.gov