Impact of CADx on Endoscopists' Histologic Characterization of Diminutive Colorectal Polyps
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 363
- Locations
- 1
- Primary Endpoint
- Pass rate for the "resect and discard" strategy
Overview
Brief Summary
This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.
Detailed Description
This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.
In this randomized controlled trial, endoscopists will be assigned to one of three arms: no CADx assistance, CADx assistance without predicted probability, or CADx assistance with predicted probability. The CADx system provides NICE-based histology predictions (Type 1 vs Type 2), which endoscopists may use to support optical diagnosis and subsequent management decisions, including surveillance interval recommendations when applicable. Outcomes will compare endoscopist-level pass rates and diagnostic performance metrics relevant to PIVI-based adoption, with histopathology as the reference standard where applicable.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Endoscopists with NBI experience
Exclusion Criteria
- •Endoscopists without colonoscopy and NBI experience
Arms & Interventions
Standard Colonoscopy (No CADx Assistance)
Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) without any CADx assistance.
CADx Without Predicted Probability
Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using NBI, with CADx-displayed NICE classification predictions but without any predicted probability information.
Intervention: CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display (Device)
CADx With PPredicted Probability
Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using NBI, with CADx-displayed NICE classification predictions and accompanying predicted probability information.
Intervention: CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display (Device)
Outcomes
Primary Outcomes
Pass rate for the "resect and discard" strategy
Time Frame: 14 days
Proportion of endoscopists who achieve ≥90% accuracy in correctly predicting the patient's recommended surveillance colonoscopy interval according to the 2020 U.S. Multi-Society Task Force (USMSTF) consensus recommendations.
Pass rate for the "diagnose and leave" strategy
Time Frame: 14 days
Proportion of endoscopists who achieve a negative predictive value (NPV) ≥90% for neoplastic lesions among rectosigmoid polyps, when predictions are made with high diagnostic confidence
Secondary Outcomes
- Pass rate for the ESGE 2020-based "resect and discard" strategy(14 days)
- Pass rate for the APWG 2022-based "resect and discard" strategy(14 days)
- Pass rate for the China 2023-based "resect and discard" strategy(14 days)
- SODA-1 achievement rate(14 days)
- SODA-2 achievement rate(14 days)
- Proportion of high-confidence optical diagnoses(14 days)
- Accuracy of high-confidence optical diagnosis (neoplastic vs non-neoplastic)(14 days)
Investigators
Xiaobo Li
Chief physician
Shanghai Jiao Tong University School of Medicine