Esophagogastroduodenoscopy
Conditions
Keywords
Esophagogastroduodenoscopy, Gastric Cancer, esophageal cancer, Artificial Intelligence, Quality-control
Brief summary
The purpose of our study was to assess the performance of esophagogastroduodenoscopy automatic quality-control system in real-time quality control of EGD.
Detailed description
Investigators developed a real-time quality control system of esophagogastroduodenoscopy(EGD) named EGD automatic quality-control system (AQCS). Investigators carried a prospective multicenter randomized controlled trial to assess the performance of this system in quality control of real-time EGD, including detecting the early upper gastrointestinal cancer and precancerous lesions, assessing inspection completeness, mucosal visibility, time of EGD procedure and other indicators.
Interventions
DEVICEComputer-aided Real-time Automatic Quality-control System
EGD automatic quality-control system(AQCS),developed based on deep convolutional neural network (DCNN) models,could facilitate real-time detection of upper gastrointestinal lesions, assess inspection completeness and mucosal visibility, and calculate time of EGD procedure.
Sponsors
Binzhou Medical University
Shengli Oilfield Hospital
Peking University Care Luzhong Hospital
Linyi People's Hospital
Zibo Municipal Hospital
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 40-80 years old * Patients scheduled for white light EGD examination with anaesthesia * American Society of Anesthesiology risk class 1, 2 or 3
Exclusion criteria
* Patients with known advanced esophageal or gastric cancer * Patients with a history of esophageal or gastric surgery * Patients scheduled for therapeutic EGD * Patients with stenosis or obstruction of upper gastrointestinal tract * Patients with a history of serious anesthesia-related complications * Patients in pregnancy or lactation phase * Patients refused to sign the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination | 6 months | The primary outcome is the detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination per group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract in tertiary hospitals and secondary hospitals. | 6 months | Effect of detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from tertiary hospitals and secondary hospitals with assistance of AQCS. |
| Mean inspection completeness of two groups. | 6 months | Inspection completeness includes taking standard images of each parts of esophageal and gastric cavity. |
| Mean inspection time of EGD procedure of two groups. | During procedure | Inspection time of EGD procedure is the time endoscopy inserting to withdrawing the mouth and does not include the time of biopsy. |
| Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS. | 6 months | Effect of detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS. |
Countries
China
Outcome results
None listed