Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors: a Multi-center, Prospective, Controlled Study

Conditions
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Gastroscopy Time, Early Gastric Cancer, Detection Rate

Intervention / Treatment
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* Other: Set the minimum time of gastroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Set the minimum time of gastroscopy<br> | Other: Set the minimum time of gastroscopy<br>* 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.<br>|
| No Intervention: Observe the procedure time of gastroscopy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| focal lesion detection rate | number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate of high risk lesions | 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 | two months | 
| endoscopic biopsy rate | number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures | two months | 
| detection rate of neoplastic lesions | number of gastroscopy procedures that detect upper GI cancers divided by the number of all gastroscopy procedures | two months | 
| mean (median) examination time for normal EGDs without biopsy | mean (median) examination time for all normal EGDs without biopsy | two months | 
| rate of procedures reaching the minimal time | number of gastroscopy procedures that reach the minimal time divided by the number of all gastroscopy procedures | two months |