Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors: a Multi-center, Prospective, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- focal lesion detection rate
研究概览
简要总结
This multicenter, prospective, interventional study aims to include 2000 gastroscopic procedures and investigate the relationship between procedure time and lesion detection rate in tertiary endoscopic centers in China. At the first stage, the researchers observe the actual procedure time of gastroscopies without affecting the natural behavior of endoscopists. At the second stage, a minimal time limit will be set for each procedure based on the observational results of the first stage. The primary study outcome is focal lesion detection rate. Secondary outcomes include detection rate of early upper GI cancer, biopsy rate and adverse event rate.
详细描述
China is a country with a heavy burden of gastric cancer and esophageal cancer. In 2015, the incidence/mortality of gastric cancer and esophageal cancer in China were 680000/500000 and 220000/200000, respectively. Gastroscopy is the most important means to detect early cancer of gastrointestinal tract. However, due to various factors, the miss rate of clinical significant lesions by gastroscopy is innegligible. Our previous research results showed that the detection rate of early gastric cancer and early esophageal cancer in China was only about 15%. This study aims to include 2000 gastroscopic procedures and investigate the relationship between procedure time and lesion detection rate in tertiary endoscopic centers in China.
At the first stage, the researchers observe the actual procedure time of gastroscopies without affecting the natural behavior of endoscopists. Then, researchers collect the data (including focal lesion detection rate, procedure time, detection rate of early upper GI cancer, biopsy rate and adverse event rate) and analyze the minimal procedure time. At the second stage, a minimal time limit will be set for each procedure. Every stage last two months, and potential correlations between lesion detection rate and procedure time will be investigated through subsequent statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of benign and malignant tumors (including carcinoma and adenoma) of upper GI (including esophagus, stomach and duodenum)
- •undergo gastroscopy with intravenous anesthesia (or conscious sedation)
排除标准
- •Subjects with focal lesions detected by gastroscopy within 1 year
- •Subjects that cannot stand the gastroscopy procedure or cannot cooperate with endosccopists
- •Emergency endoscopy and therapeutic endoscopy
- •Subjects with history of esophageal or stomach surgery or endoscopic surgery
- •Subjects that taking antiplatelet or anticoagulant drugs which contradicts endoscopic biopsy
- •Subjects with other serious complications that affect the speed of gastroscopy
- •Subjects that refuse to cooperate with data collection or sign the informed consent
结局指标
主要结局
focal lesion detection rate
时间窗: two months
number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures
次要结局
- rate of procedures reaching the minimal time(two months)
- mean (median) examination time for normal EGDs without biopsy(two months)
- detection rate of neoplastic lesions(two months)
- detection rate of high risk lesions(two months)
- endoscopic biopsy rate(two months)
研究者
Zhaoshen Li
Director of Gastroenterology
Changhai Hospital