A Multi-center, Randomized, Controlled Clinical Study on the Efficacy of Artificial Intelligence-Assisted Colonoscopy in Improving the Screening of Colorectal Cancer and Precancerous Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,342
- 试验地点
- 1
- 主要终点
- Adenoma Detection Rate (ADR)
研究概览
简要总结
This study is a multi-center, randomized controlled trial designed to evaluate whether an artificial intelligence (AI) system can assist endoscopists to improve the detection rate of colorectal adenomas and cancers during colonoscopy compared to standard colonoscopy. Early screening and diagnosis are key to reducing the burden of colorectal cancer, but current colonoscopy has limitations, including the risk of missed lesions. This trial aims to determine if AI can enhance screening quality and diagnostic accuracy.
详细描述
Colorectal cancer (CRC) screening is crucial for early detection and reducing mortality, yet current colonoscopy techniques face challenges such as variable adenoma detection rates (ADR) and the risk of missed diagnoses for subtle lesions. This study is a prospective, multi-center, parallel-group, randomized controlled trial aiming to validate the clinical value of an AI-assisted diagnostic system in improving screening quality. A total of 3342 participants will be randomized in a 1:1 ratio to undergo either AI-assisted colonoscopy (Experimental Group) or conventional high-definition colonoscopy (Control Group). The primary objective is to compare the ADR between the two groups. Secondary objectives include assessing the detection rate of advanced or specific types of polyps, the mean number of adenomas per procedure, and the impact of the AI system on both patient and physician satisfaction. The study will provide high-quality evidence for the standardized application of AI technology in CRC screening, with the ultimate goal of reducing the incidence and mortality of colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years, inclusive.
- •Scheduled for a screening, diagnostic, or surveillance colonoscopy.
- •Able to understand the study protocol and provide written informed consent.
排除标准
- •Known contraindications to colonoscopy or biopsy.
- •Personal history of colorectal cancer, inflammatory bowel disease (IBD), or previous colorectal surgery.
- •Known or suspected colorectal polyposis syndrome (e.g., Familial Adenomatous Polyposis - FAP).
- •Patients with active colorectal bleeding, bowel obstruction, or toxic megacolon.
- •Women who are pregnant, planning to become pregnant, or are breastfeeding.
- •Participation in another interventional clinical trial within the 30 days prior to enrollment.
- •Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
研究组 & 干预措施
Experimental: AI-Assisted Colonoscopy
Participants will undergo a high-definition colonoscopy procedure where a real-time artificial intelligence system analyzes the video feed to assist the endoscopist in identifying and highlighting suspicious lesions.
干预措施: AI-Assisted Colonoscopy (Device)
Control: Conventional Colonoscopy
Participants will undergo a standard high-definition colonoscopy procedure performed by a qualified endoscopist without the assistance of the artificial intelligence system. The AI software will not be active during these procedures.
结局指标
主要结局
Adenoma Detection Rate (ADR)
时间窗: From the day of the procedure up to 14 days post-procedure.
The proportion of participants with at least one histologically confirmed colorectal adenoma or adenocarcinoma. Detection and specimen collection occur during the colonoscopy, with final confirmation based on pathology reports.
次要结局
- Mean Adenomas Per Colonoscopy (APC)(From the day of the procedure up to 14 days post-procedure.)
- Advanced Adenoma and Sessile Serrated Adenoma/Polyp (SSA/P) Detection Rate(From the day of the procedure up to 14 days post-procedure.)
- Patient Satisfaction Score(Assessed within 1 hour after completion of the colonoscopy procedure.)
- Physician Satisfaction Score(Assessed within 1 hour after completion of the colonoscopy procedure.)
- Incidence of Procedure-Related Adverse Events(From the start of the procedure up to 30 days post-procedure.)
研究者
Ding Ke-Feng
Clinical professor
Zhejiang University