Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

Study Overview
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Brief Summary
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The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.

Detailed Description
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In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.

Official Title
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Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms

Conditions
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Esophagogastroduodenoscopy

Intervention / Treatment
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* Other: automatic quality-control system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing EGD examination with anaesthesia; patients able to give informed consent. Exclusion Criteria: patients with the contraindications to EGD examination; patients with a prior EGD examination within 1 year before the trial; patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy; a history of upper gastrointestinal cancers; allergic to anaesthetic in previous medical history; patients refused to participate in the trial; the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EAS-aided group<br>esophagogastroduodenoscopy examination with the assistance of automatic quality-control system | Other: automatic quality-control system<br>* Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.<br>|
| No Intervention: control group<br>conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate of gastric neoplasms | detection rate of gastric neoplasms in different groups | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean number of gastric neoplasms detected | mean number of gastric neoplasms detected per procedure in different groups | 8 months | 
| mean inspection completeness | inspection completeness per procedure in different groups | 8 months | 
| mean inspection time | inspection time per procedure in different groups | 8 months | 
| errors of EAS | errors of EAS in EAS-aided group | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagogastroduodenoscopy, gastric neoplasm, artificial intelligence, quality control