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Completed

NCT Number: NCT07389759

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

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.

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Key information

Conditions

Colorectal Polyps

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endoscopists with NBI experience

Exclusion criteria

-Endoscopists without colonoscopy and NBI experience

Treatment and study plan

CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display

Device

CADx-assisted optical diagnosis (NBI; predicted probability not displayed). Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) with CADx-displayed NICE classification predictions for each polyp. In this arm, the CADx output is displayed without any predicted probability information.

CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display

Device

CADx-assisted optical diagnosis (NBI; predicted probability displayed). Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) with CADx-displayed NICE classification predictions for each polyp. In this arm, the CADx output is displayed with accompanying predicted probability information.

Primary outcomes

  1. 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.

  2. 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

  1. Pass rate for the ESGE 2020-based "resect and discard" strategy

    Time frame: 14 days

    The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the ESGE 2020 guideline.

  2. Pass rate for the APWG 2022-based "resect and discard" strategy

    Time frame: 14 days

    The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the APWG 2022 consensus.

  3. Pass rate for the China 2023-based "resect and discard" strategy

    Time frame: 14 days

    The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the Chinese 2023 consensus.

  4. SODA-1 achievement rate

    Time frame: 14 days

    The proportion of endoscopists who, when reporting high diagnostic confidence, meet the SODA-1 performance thresholds for diagnosing neoplastic pathology in diminutive rectosigmoid polyps, as assessed by sensitivity of at least 90% and specificity of at least 80%, with histopathology as the reference standard.

  5. SODA-2 achievement rate

    Time frame: 14 days

    The proportion of endoscopists who, when reporting high diagnostic confidence, meet the SODA-2 performance thresholds for diagnosing neoplastic pathology in diminutive colorectal polyps, as assessed by sensitivity of at least 80% and specificity of at least 80%, with histopathology as the reference standard.

  6. Proportion of high-confidence optical diagnoses

    Time frame: 14 days

    For each endoscopist, the percentage of polyp assessments that are labeled as high diagnostic confidence among all polyp assessments performed.

  7. Accuracy of high-confidence optical diagnosis (neoplastic vs non-neoplastic)

    Time frame: 14 days

    For each endoscopist, the percentage of correct classifications (neoplastic vs non-neoplastic) among assessments labeled as high diagnostic confidence, using histopathology as the reference standard.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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