Impact of CADx on Endoscopists' Histologic Characterization of Diminutive Colorectal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 399
- 试验地点
- 1
- 主要终点
- Pass rate for the "resect and discard" strategy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endoscopists with NBI experience
排除标准
- •Endoscopists without colonoscopy and NBI experience
研究组 & 干预措施
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.
干预措施: 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.
干预措施: CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display (Device)
结局指标
主要结局
Pass rate for the "resect and discard" strategy
时间窗: 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
时间窗: 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
次要结局
- 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)
研究者
Xiaobo Li
Chief physician
Shanghai Jiao Tong University School of Medicine