Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors
Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors: a Multi-center, Prospective, Controlled Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Shanghai、中国、200433
- Changhai Hospital, Second Military Medical University
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Shanghai、中国、200433
- Changhai Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Pregnant
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Set the minimum time of gastroscopy
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This study contains 2 stages.
At the first stage, no interventions are implemented.
The researchers just observe the actual procedure time of gastroscopy.
At the second stage, a minimal procedure time is set based on the observational results of the first stage.
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无干预：Observe the procedure time of gastroscopy
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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focal lesion detection rate
大体时间：two months
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number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures
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two months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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detection rate of high risk lesions
大体时间：two months
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number of gastroscopy procedures that detect upper GI cancers (gastric or esophageal cancer), dysplasia and intestinal metaplasia divided by the number of all gastroscopy procedures
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two months
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endoscopic biopsy rate
大体时间：two months
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number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures
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two months
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detection rate of neoplastic lesions
大体时间：two months
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number of gastroscopy procedures that detect upper GI cancers divided by the number of all gastroscopy procedures
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two months
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mean (median) examination time for normal EGDs without biopsy
大体时间：two months
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mean (median) examination time for all normal EGDs without biopsy
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two months
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rate of procedures reaching the minimal time
大体时间：two months
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number of gastroscopy procedures that reach the minimal time divided by the number of all gastroscopy procedures
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two months
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合作者和调查者
调查人员
- 首席研究员：Ye Gao、Changhai Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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