Clinical Trial: Educational Effectiveness of AI-Based Feedback in Early Upper Gastrointestinal Endoscopy Training for Non-Expert Endoscopists: A Non-Inferiority Randomized Controlled Trial Based on Completeness of Mucosal Visualization and Image Quality (Japan)

Tokyo, June 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061701) titled 'Study on the Educational Effectiveness of AI-Based Feedback in Upper Gastrointestinal Endoscopy Training' on June 8.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - Adults undergoing diagnostic upper gastrointestinal endoscopy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate whether upper gastrointestinal endoscopy training using feedback based on AI-generated analysis reports is non-inferior to conventional supervisor-based feedback in terms of procedural completeness among non-expert endoscopists in the early phase of training. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 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 clinical practice. After each procedure, coded endoscopic images will be analyzed in the cloud using the same AI algorithm, gastro BASE screening X, and an AI-generated report including the completeness score and image-quality indicators will be provided to the operator. The operator will conduct self-reflection based on brief feedback after each case and summary reviews approximately every five cases. Approximately 32 cases are planned for the AI-report period for each physician. Interventions/Control_2 - Supervisor-feedback 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 clinical practice. After each procedure, AI analysis will be performed in the same manner as in the AI-report period; 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 reviews approximately every five cases based on his or her own clinical judgment. Approximately 32 cases are planned for the supervisor-feedback period for each physician.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 512

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 30 Day Anticipated trial start date - 2026 Year 06 Month 08 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070578

Disclaimer: Curated by HT Syndication.