Computer-aided Real-time Automatic Quality-control System for Detection of Early Cancer and Precancerous Lesions on Upper Gastrointestinal Tract: a Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,840
- 试验地点
- 6
- 主要终点
- Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination
研究概览
简要总结
The purpose of our study was to assess the performance of esophagogastroduodenoscopy automatic quality-control system in real-time quality control of EGD.
详细描述
Investigators developed a real-time quality control system of esophagogastroduodenoscopy(EGD) named EGD automatic quality-control system (AQCS). Investigators carried a prospective multicenter randomized controlled trial to assess the performance of this system in quality control of real-time EGD, including detecting the early upper gastrointestinal cancer and precancerous lesions, assessing inspection completeness, mucosal visibility, time of EGD procedure and other indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-80 years old
- •Patients scheduled for white light EGD examination with anaesthesia
- •American Society of Anesthesiology risk class 1, 2 or 3
排除标准
- •Patients with known advanced esophageal or gastric cancer
- •Patients with a history of esophageal or gastric surgery
- •Patients scheduled for therapeutic EGD
- •Patients with stenosis or obstruction of upper gastrointestinal tract
- •Patients with a history of serious anesthesia-related complications
- •Patients in pregnancy or lactation phase
- •Patients refused to sign the informed consent
结局指标
主要结局
Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination
时间窗: 6 months
The primary outcome is the detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination per group.
次要结局
- Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract in tertiary hospitals and secondary hospitals.(6 months)
- Mean inspection completeness of two groups.(6 months)
- Mean inspection time of EGD procedure of two groups.(During procedure)
- Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS.(6 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University