Artificial Intelligence-assisted Optical Diagnosis for the Resect-and-discard Strategy in Clinical Practice in Non-academic Hospitals: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 363
- 试验地点
- 2
- 主要终点
- Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines
研究概览
简要总结
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.
详细描述
This study will: (1) develop and refine a deep learning model for optical diagnosis of diminutive colorectal polyps-predicting histologic type and the presence of advanced adenoma components-based on multicenter endoscopic videos; (2) conduct a randomized controlled study recruiting endoscopists from different regions and experience levels nationwide to evaluate, with or without access to the model's diagnostic output, the success rates of implementing the "resect and discard" and "diagnose and leave" strategies as well as identifying advanced adenoma components; and (3) carry out a prospective randomized controlled trial to assess the benefits of a real-time AI-assisted endoscopic system in facilitating endoscopists' implementation of the "resect and discard" and "diagnose and leave" strategies for diminutive colorectal polyps.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
- •Known polyposis syndromes;
- •Patients with gastrointestinal bleeding;
- •Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
- •Patients with contraindications to tissue biopsy;
- •Previous history of allergic reactions to bowel cleansing agent components;
- •Suffering from intestinal obstruction or perforation, toxic megacolon, heart failure (Grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, etc.;
- •Patient's bowel preparation BBPS score <6 for this colonoscopy;
- •Researchers consider the patient unsuitable for trial participation.
研究组 & 干预措施
CADx assisted colonoscopy group
干预措施: AI-Assisted Real-time Endoscopic Diagnosis System (Device)
Routine colonoscopy group
Endoscopists perform standard endoscopic diagnosis using conventional NBI-based NICE classification without AI assistance.
结局指标
主要结局
Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines
时间窗: 14 days
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.
Negative Predictive Value for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Confidence
时间窗: 14 days
次要结局
- Agreement between optical- and histology-based post-polypectomy surveillance intervals according to according to European Guidelines(14 days)
- Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Asia-Pacific Guidelines(14 days)
- Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Expert Consensus on Outpatient Management of Colorectal Polyps(14 days)
- Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Diagnostic Confidence(30 days)
- Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Diminutive Polyps under High Diagnostic Confidence(14 days)
- Diagnostic Accuracy of Endoscopists in Characterizing Colorectal Diminutive Polyps when assessed with High Diagnostic Confidence.(14 days)
- Improvement in Endoscopists' Diagnostic Confidence with AI Assistance(14 days)
- Improvement in Endoscopists' Diagnostic Accuracy in Characterizing Colorectal Diminutive Polyps with AI Assistance.(14 days)
研究者
Xiaobo Li
Chief physician
Shanghai Jiao Tong University School of Medicine