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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
2,000
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.
Changhai Hospital, Second Military Medical University
Shanghai, China
Changhai Hospital
Shanghai, China
focal lesion detection rate
number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures
Time frame: two months
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
Time frame: two months
endoscopic biopsy rate
number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures
Time frame: two months
detection rate of neoplastic lesions
number of gastroscopy procedures that detect upper GI cancers divided by the number of all gastroscopy procedures
Time frame: two months
mean (median) examination time for normal EGDs without biopsy
mean (median) examination time for all normal EGDs without biopsy
Time frame: 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
Time frame: two months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.