Colorectal Polyps
Conditions
Brief summary
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.
Detailed description
This study will: (1) develop and refine a deep learning model for optical diagnosis of diminutive colorectal polyps-predicting histologic type and the presence of advanced adenoma components-based on multicenter endoscopic videos; (2) conduct a randomized controlled study recruiting endoscopists from different regions and experience levels nationwide to evaluate, with or without access to the model's diagnostic output, the success rates of implementing the "resect and discard" and "diagnose and leave" strategies as well as identifying advanced adenoma components; and (3) carry out a prospective randomized controlled trial to assess the benefits of a real-time AI-assisted endoscopic system in facilitating endoscopists' implementation of the "resect and discard" and "diagnose and leave" strategies for diminutive colorectal polyps.
Interventions
DEVICEAI-Assisted Real-time Endoscopic Diagnosis System
CADx 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
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Agree to participate in this prospective randomized controlled study; 2. Age ≥18 years for colonoscopy; 3. At least one colorectal diminutive polyp (size \<=5mm) found during examination;
Exclusion criteria
1. Already participating in other clinical trials, having signed informed consent and being in the follow-up period of other clinical trials; 2. Already participating in drug clinical trials and being in the washout period of experimental or control drugs; 3. History of drug or alcohol abuse or psychological disorders in the past five years; 4. Pregnant or lactating patients; 5. Known polyposis syndromes; 6. Patients with gastrointestinal bleeding; 7. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery; 8. Patients with contraindications to tissue biopsy; 9. Previous history of allergic reactions to bowel cleansing agent components; 10. Suffering from intestinal obstruction or perforation, toxic megacolon, heart failure (Grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, etc.; 11. Patient's bowel preparation BBPS score \<6 for this colonoscopy; 12. Researchers consider the patient unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines | 14 days | 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 | 14 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between optical- and histology-based post-polypectomy surveillance intervals according to according to European Guidelines | 14 days | 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 | 14 days | 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 | 14 days | 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 | 30 days | — |
| Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Diminutive Polyps under High Diagnostic Confidence | 14 days | — |
| Diagnostic Accuracy of Endoscopists in Characterizing Colorectal Diminutive Polyps when assessed with High Diagnostic Confidence. | 14 days | — |
| Improvement in Endoscopists' Diagnostic Confidence with AI Assistance | 14 days | — |
| Improvement in Endoscopists' Diagnostic Accuracy in Characterizing Colorectal Diminutive Polyps with AI Assistance. | 14 days | — |
Countries
China
Contacts
CONTACTXiaobo Li, PhD
Outcome results
None listed