Impact of CADx on Endoscopists' Histologic Characterization of Diminutive Colorectal Polyps

Shanghai Jiao Tong University School of Medicine

Status: Not yet enrolling

Conditions: Colorectal Polyps

Treatments: Device: CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display; Device: CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display

Study type: Interventional

Funder types: Other

Identifiers

NCT07389759

KY2024-080-A-02

Details and patient eligibility

About

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.

Full 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 prediction probability, or CADx assistance with prediction 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.

Enrollment: 363 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Endoscopists with NBI experience

Exclusion criteria

-Endoscopists without colonoscopy and NBI experience

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

363 participants in 3 patient groups

Standard Colonoscopy (No CADx Assistance)

No Intervention group

Description:

Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) without any CADx assistance.

CADx Without Prediction probility

Experimental group

Description:

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.

Treatment:

Device: CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display

CADx With Prediction probility

Experimental group

Description:

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.

Treatment:

Device: CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display