AQCS for Detection of Early Cancer and Precancerous Lesions on Upper Gastrointestinal Tract

Study Overview
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Brief Summary
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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
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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.

Official Title
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Computer-aided Real-time Automatic Quality-control System for Detection of Early Cancer and Precancerous Lesions on Upper Gastrointestinal Tract: a Multicenter Randomized Controlled Study

Conditions
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Esophagogastroduodenoscopy

Intervention / Treatment
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* Device: Computer-aided Real-time Automatic Quality-control System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AQCS-aided group<br>Patients in AQCS-aided group will go through white light EGD examination with assistance of AQCS. | Device: Computer-aided Real-time Automatic Quality-control System<br>* 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.<br>|
| No Intervention: Control group<br>Patients in control group will go through white light EGD examination without AQCS. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination | The primary outcome is the detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination per group. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract in tertiary hospitals and secondary hospitals. | Effect of detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from tertiary hospitals and secondary hospitals with assistance of AQCS. | 6 months | 
| Mean inspection completeness of two groups. | Inspection completeness includes taking standard images of each parts of esophageal and gastric cavity. | 6 months | 
| Mean inspection time of EGD procedure of two groups. | Inspection time of EGD procedure is the time endoscopy inserting to withdrawing the mouth and does not include the time of biopsy. | During procedure | 
| Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS. | Effect of detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagogastroduodenoscopy, Gastric Cancer, esophageal cancer, Artificial Intelligence, Quality-control