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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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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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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：Observe the procedure time of gastroscopy
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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focal lesion detection rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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detection rate of high risk lesions
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ye Gao、Changhai Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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