Real-World Experience of Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital: a Single-Center Cohort Phase IV Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Chirec
- 入组人数
- 765
- 试验地点
- 2
- 主要终点
- Adenoma Detection Rate in Conventional versus Artificial Intelligence-Assisted Colonoscopy
研究概览
简要总结
Cancer can develop in the colon, or large bowel. Examination of the colon with a tube fitted with a camera is called a colonoscopy.
Colonoscopy allows detection of small growths in the colon, called "polyps". Polyps can often be removed during colonoscopy. Some of these polyps are called adenomas and can become cancer after several years.
A good colonoscopy aims to find and take out as many of these polyps as possible.
A quality indication of colonoscopy is the "adenoma detection rate" (ADR). It should be high, meaning many polyps are detected and taken out.
New artificial intelligence devices to assist colonoscopy seem to increase the ADR, and maybe help prevent cancer even better than normal colonoscopy.
The goal of this clinical trial is to compare the ADR when using standard colonoscopy to the ADR with artificial intelligence (AI)-assisted colonoscopy.
详细描述
The colon is a part of the bowel where colon cancer can develop.
It is possible to prevent colon cancer by doing a screening test called a colonoscopy.
The colonoscopy procedure allows detection of "polyps" which can often be removed during the procedure. Some of these polyps are called adenomas and can become cancer after several years.
A good colonoscopy aims to find and take out as many of these polyps as possible.
A quality indication of colonoscopy is the "adenoma detection rate" (ADR). It should be high, meaning many polyps are detected and taken out.
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
- None
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient (woman or man) candidate for a screening colonoscopy - Age: 45 to 74 years included
- •Absence of inflammatory bowel disease
- •Absence of significant digestive symptoms indicating colonoscopy (i.e. screening is the only indication for the examination)
- •Patient able to understand the concept of the study and agreeing to participate
排除标准
- •Patient outside the inclusion age
- •All exclusion criteria for a colonoscopy.
- •The indication for colonoscopy is not simple screening; for example, assessment of anemia, rectal bleeding, weight loss or abdominal pain.
- •Patient's refusal to participate, or patient's inability to understand the study concept
- •Any patient with major psychological or psychiatric disorders.
结局指标
主要结局
Adenoma Detection Rate in Conventional versus Artificial Intelligence-Assisted Colonoscopy
时间窗: 1 day
The main objective of this study is the difference in the detection rate of colorectal adenomas in individuals over 45 years old during colonoscopies for colon cancer screening between a conventional colonoscopy procedure (CCP) and a colonoscopy procedure with AI (ACP).
次要结局
- The difference in the detection rate of colorectal adenomas according to size by group (5 mm/6-9 mm/>10 mm) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).(1 day)
- The difference in detection rate of colorectal adenomas based on dysplastic grade by group(1 day)
- The difference in the detection rate of colorectal adenomas according to the number per group (n=1-2/n= 3-10/n >10) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).(1 day)
- The difference in the detection rate of colorectal adenomas according to experience by group of colonoscopists(1 day)
- The difference in the detection rate of colorectal adenomas based on histology by group (hyperplastic/conventional adenomas/serrated adenomas/adenocarcinoma) between a conventional colonoscopic procedure (PCC) and a colonoscopy procedure with AI.(1 month)
- The difference in the detection rate of colorectal adenomas depending on the location by group (rectum/left colon/transverse colon/right colon) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).(1 day)
- The difference in the detection rate of colorectal adenomas depending on the time of day .(1 day)
- The difference in the detection rate of colorectal adenomas according to colonic preparation by group (Boston Score 9/6-8/<6) between a conventional colonoscopic procedure (PCC) and a colonoscopy procedure with AI (ACP).(1 day)