AI-Assisted Real-Time Endoscopic Characterization of Diminutive Colorectal Polyps in Non-Academic Hospitals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Jiao Tong University School of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • AI-Assisted Real-time Endoscopic Diagnosis System

    Device

    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

Treatment groups

363 Participants
are divided into 2 treatment groups
Group A: CADx assisted colonoscopy groupExperimental treatment 1 intervention
Group B: Routine colonoscopy groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
14 days
2

Negative Predictive Value for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Confidence

Time frame
14 days

Secondary outcomes

1

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.

Time frame
14 days
2

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.

Time frame
14 days
3

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).

Time frame
14 days
4

Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Diagnostic Confidence

Time frame
30 days

Other outcomes

Sponsors and contacts

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