Impact of Automatic Polyp Detection System on Adenoma Detection Rate-a Multicenter,Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,118
- 试验地点
- 1
- 主要终点
- adenoma detection rate(ADR)
研究概览
简要总结
In recent years, with the continuous development of artificial intelligence, automatic polyp detection systems have shown its potential in increasing the colorectal lesions. Yet, whether this system can increase polyp and adenoma detection rates in the real clinical setting is still need to be proved. The primary objective of this study is to examine whether a combination of colonoscopy and a deep learning-based automatic polyp detection system is a feasible way to increase adenoma detection rate compared to standard colonoscopy.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 40-85 years old who have indications for screening, surveillance and diagnostic.
- •Patients who have signed inform consent form.
排除标准
- •Patients who have undergone colonic resection
- •Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- •Patients with severe chronic cardiopulmonary and renal disease.
- •Patients who are unwilling or unable to consent.
- •Patients who are not suitable for colonoscopy
- •Patients who received urgent or therapeutic colonoscopy
- •Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
- •Patients who are taking aspirin, clopidogrel or other anticoagulants
- •Patients with withdrawal time < 6 min
研究组 & 干预措施
AI-assisted withdrawal group
A deep learning-based automatic polyp detection system was used to assist the endoscopist.
干预措施: Automatic polyp detection system (Device)
Routine withdrawal group
Routine withdrawal without any assist.
结局指标
主要结局
adenoma detection rate(ADR)
时间窗: 30 minutes
the number of patients with at least one adenoma divided by the total number of patients.
次要结局
- adenoma per colonoscopy(30 minutes)
- polyp per colonoscopy(30 minutes)
- polyp detection rate(PDR)(30 minutes)
研究者
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital