Adults undergoing diagnostic upper gastrointestinal endoscopy
Conditions
Interventions
AI-report period: During weekly or daily time blocks assigned to each participating physician within the registration period, upper gastrointestinal endoscopy will be performed as part of routine clin
however, the AI-generated results will not be disclosed to either the operator or the supervisor during the feedback period. The supervisor will provide brief feedback after each case and summary revi
Sponsors
St. Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria: Patients aged 20 years or older, regardless of sex, who undergo diagnostic upper gastrointestinal endoscopy. Eligible indications include health check-up, dyspepsia, follow-up after Helicobacter pylori eradication, follow-up of ulcers or erosions, follow-up of chronic gastritis, and evaluation of functional gastrointestinal disorders. Patients should be classified as ASA physical status I or II and be able to undergo endoscopy with standard preparation and sedation. Patients who do not opt out after public disclosure of the study information will be included. Physician inclusion criteria: Physicians who have not yet obtained board certification from the Japan Gastroenterological Endoscopy Society, have performed approximately 50 to 300 upper gastrointestinal endoscopies independently, and are able to perform the procedure safely. Physicians must be able to perform approximately four cases per week for about 16 weeks and comply with the predefined allocation to the AI-report and supervisor-feedback periods. Written informed consent must be obtained from participating physicians.
Exclusion criteria
Exclusion criteria: Patient exclusion criteria: Patients undergoing endoscopy for therapeutic or detailed diagnostic purposes, including evaluation of suspected cancer, active bleeding, varices, marked stenosis, or planned EMR or ESD. Patients with anatomical conditions that substantially deviate from the standard observation map, such as post-gastrectomy status or Roux-en-Y reconstruction, will be excluded. Patients classified as ASA physical status III or IV, emergency cases, those with severe comorbidities, contraindications to sedation, or pregnancy will be excluded. Patients who opt out after public disclosure of the study information or withdraw from study participation will also be excluded. Patients judged by the principal investigator or co-investigators to be unsuitable for endoscopy by a beginner will be excluded. Physician exclusion criteria: Physicians who have already obtained board certification from the Japan Gastroenterological Endoscopy Society or are too highly experienced to allow evaluation of the educational effect will be excluded. Physicians who cannot comply with the allocation during the study period or who do not provide consent will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The case-level completeness of mucosal visualization score (%) calculated by the same AI algorithm (gastro BASE screening X) after each eligible upper gastrointestinal endoscopy performed during the registration period. The between-period difference in the completeness score between the AI-report period and the supervisor-feedback period will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| For each eligible upper gastrointestinal endoscopy performed during the registration period, the following outcomes will be assessed after the procedure or after AI analysis: procedure time, total number of captured images, number of gastric images, number of gastric image-enhanced endoscopy images, number of gastric chromoendoscopy images, number of biopsies, number of lesions diagnosed as Group 2 or higher, number of images with inadequate image quality, operator-level improvement rate in the completeness score, and inter-operator variability. | — |
Countries
Japan
Contacts
Public ContactTadateru Maehata
St. Marianna University School of Medicine Department of Gastroenterology
Outcome results
None listed