NCT03883035已完成不适用
Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms
Yanqing Li1 个研究点 分布在 1 个国家目标入组 1,060 人开始时间: 2019年3月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,060
- 试验地点
- 1
- 主要终点
- detection rate of gastric neoplasms
研究概览
简要总结
The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.
详细描述
In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.
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
- Double (Participant, Outcomes Assessor)
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 undergoing EGD examination with anaesthesia;
- •patients able to give informed consent.
排除标准
- •patients with the contraindications to EGD examination;
- •patients with a prior EGD examination within 1 year before the trial;
- •patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;
- •a history of upper gastrointestinal cancers;
- •allergic to anaesthetic in previous medical history;
- •patients refused to participate in the trial;
- •the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.
结局指标
主要结局
detection rate of gastric neoplasms
时间窗: 8 months
detection rate of gastric neoplasms in different groups
次要结局
- mean inspection completeness(8 months)
- mean number of gastric neoplasms detected(8 months)
- mean inspection time(8 months)
- errors of EAS(8 months)
研究者
Yanqing Li
vice president of Qilu Hospital
Shandong University
研究点 (1)
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