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

Not Applicable

Completed

• Conditions: Esophagogastroduodenoscopy
• Interventions: Device: Computer-aided Real-time Automatic Quality-control System

• Registration Number: NCT04720924
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2021-01-16
• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-25
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AQCS-aided group	Computer-aided Real-time Automatic Quality-control System	Patients in AQCS-aided group will go through white light EGD examination with assistance of AQCS.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

PKUcare Luzhong Hospital; 🇨🇳 Zibo, Shandong, China

Zibo Municipal Hospital; 🇨🇳 Zibo, Shandong, China

Binzhou Medical University Hospital; 🇨🇳 Binzhou, Shandong, China

Linyi People's Hospital; 🇨🇳 Dezhou, Shandong, China

Central Hospital of Shengli Oilfield; 🇨🇳 Dongying, Shandong, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China