Clinical trial NCT04602299: Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors
Official title: Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors: a Multi-center, Prospective, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroscopy Time
Early Gastric Cancer
Detection Rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: focal lesion detection rate
timeFrame: two months
Secondary outcomes:
measure: detection rate of high risk lesions
timeFrame: two months
measure: endoscopic biopsy rate
timeFrame: two months
measure: detection rate of neoplastic lesions
timeFrame: two months
measure: mean (median) examination time for normal EGDs without biopsy
timeFrame: two months
measure: rate of procedures reaching the minimal time
timeFrame: two months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Ye Gao
role: PRINCIPAL_INVESTIGATOR
References: