Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps: a Prospective Randomized Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Detection rate of small polyps (diameter < 6mm)
研究概览
简要总结
All subjects shall sign informed consent before screening, and subjects shall be included according to inclusion and exclusion criteria.
A total of four endoscopists were included in the study, two in each group of senior endoscopists and two in each group of junior endoscopists.
Patients were randomly enrolled into the senior endoscopy group and the junior endoscopy group, and received artificial intelligence assisted colonoscopy and conventional colonoscopy successively. The two colonoscopy methods were performed back to back by different endoscopy physicians with the same seniority.
All patients were examined and treated according to routine medical procedures. The routine colonoscopy group and the artificial-intelligence-assisted colonoscopy group made detailed records of the patients' withdrawal time, entry time, number of polyps detected, polyp Paris classification, polyp size, polyp shape, polyp location and intestinal preparation during the colonoscopy process
详细描述
This is a prospective randomized clinical study.This study was conducted in the Endoscopy Center of the Nanfang Hospital, China. Routine bowel preparation consisted of 4 L of polyethylene glycol, given in split doses. Colonoscopies were performed with high definition colonoscopes and high-definition monitors.
All subjects shall sign informed consent before screening, and subjects shall be included according to inclusion and exclusion criteria.
A total of four endoscopists were included in the study, two in each group of senior endoscopists (>1000 colonoscopies) and two in each group of junior endoscopists ( <1000 colonoscopies).
Patients were randomly enrolled into the senior endoscopy group and the junior endoscopy group, and received artificial intelligence assisted colonoscopy and conventional colonoscopy successively. The two colonoscopy methods were performed by different endoscopy physicians back to back with the same seniority.
All patients were examined and treated according to routine medical procedures (outpatient patients and inpatients who did not sign the consent form for polypectomy were not resected for the lesions detected during the examination, while inpatients who signed the consent form for polypectomy were left in the original position after the first colonoscopy and removed at the end of the second examination).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese population aged 18-80 years old; Patients voluntarily signed informed consent form; In accordance with the indications of colonoscopy.
排除标准
- •(IBD) history of inflammatory bowel disease; History of colorectal surgery; Previous failed colonoscopy; Polyposis syndrome; Highly suspected colorectal cancer (CRC)
研究组 & 干预措施
Artificial intelligence assisted colonoscopy group
The real-time automatic polyp detection system was used to assist the endoscopist.
干预措施: Artificial intelligence assisted colonoscopy (Device)
Routine colonoscopy group
The patient underwent routine colonoscopy.
结局指标
主要结局
Detection rate of small polyps (diameter < 6mm)
时间窗: 6 months
In each group, the number of patients with small polyps was detected as a percentage of the total number of patients.
次要结局
- Number of polyps detected(6 months)
- Polyp size(6 months)
- Polyp morphology(6 months)
研究者
Side Liu
professor
Nanfang Hospital, Southern Medical University