A Multi-center, Randomized, Controlled Clinical Study on the Effectiveness of Artificial Intelligence-Assisted Colonoscopy in Improving the Screening of Colorectal Cancer and Precancerous Lesions in Routine Clinical Practice Across Tertiary Academic Medical Centers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,300
- 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 3300 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
- Single (Participant)
盲法说明
Participants are blinded to group assignment. Endoscopists performing the procedures cannot be blinded, which is an inherent limitation of computer-aided detection trials. Histopathological assessment, Boston Bowel Preparation Scale scoring by a second observer, outcome adjudication, and statistical analysis are performed by blinded personnel; the statistician remains blinded until database lock.
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40 to 74 years, inclusive; men and women.
- •Scheduled for elective screening, diagnostic, or surveillance colonoscopy.
- •In generally good condition, mentally competent, and willing to provide written informed consent.
排除标准
- •Known contraindication to colonoscopy or to biopsy.
- •History of colon cancer or previous colonic surgery.
- •Bowel obstruction; confirmed or highly suspected colorectal cancer; inflammatory bowel disease; or active colorectal bleeding.
- •Colorectal polyposis, including a history of familial adenomatous polyposis.
- •Pregnancy or breastfeeding.
- •Participation in another drug or medical device clinical trial within 1 month before enrollment.
- •Any other condition that, in the investigator's judgment, makes the participant unsuitable for this trial.
- •Withdrawal Criteria:
- •Withdrawal of consent by the participant.
- •Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score below 6 or any segment score below
- •Failure to reach the cecum.
- •Newly diagnosed active colitis during the procedure.
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
- Advanced adenoma detection rate(From the day of the procedure up to 14 days post-procedure.)
- Serrated lesion detection rate(From the day of the colonoscopy up to 14 days after the procedure.)
- Proximal adenoma detection rate(From the day of the colonoscopy up to 14 days after the procedure.)
- 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