About this trial
To validate the feasibility of promoting colorectal diminutive polyp "predict, resect, and discard" and "diagnose and leave" strategies for non-experts in general hospitals through CADx system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Agree to participate in this prospective randomized controlled study;
Age ≥18 years for colonoscopy;
At least one colorectal diminutive polyp (size <=5mm) found during examination;
Disqualifiers
Already participating in other clinical trials, having signed informed consent and being in the follow-up period of other clinical trials;
Already participating in drug clinical trials and being in the washout period of experimental or control drugs;
History of drug or alcohol abuse or psychological disorders in the past five years;
Pregnant or lactating patients;
Trial design
Parallel
Treatments tested in this trial
AI-Assisted Real-time Endoscopic Diagnosis System
DeviceCADx assists endoscopists in diagnosing colorectal diminutive polyps (\<=5cm) during colonoscopy using narrow-band imaging (NBI). The system provides real-time prediction values of NICE classification for colorectal polyp. The intervention group receives AI-assisted diagnostic information displayed
Treatment groups
Trial outcomes
Primary outcomes
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines
The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the U.S. 2020 USMSTF consensus for post-polypectomy surveillance.
Negative Predictive Value for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Confidence
Secondary outcomes
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to according to European Guidelines
The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the European ESGE 2020 consensus for post-polypectomy surveillance.
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Asia-Pacific Guidelines
The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the Asia-Pacific APWG 2022 consensus for post-polypectomy surveillance.
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Expert Consensus on Outpatient Management of Colorectal Polyps
The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the Expert Consensus on Outpatient Management of Colorectal Polyps (2025, Chengdu).
Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Diagnostic Confidence
Sponsors and contacts
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