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

N/ACompletedNCT04720924

Shandong University1,840 enrolled

Overview

The purpose of our study was to assess the performance of esophagogastroduodenoscopy automatic quality-control system in real-time quality control of EGD.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

1,840

Conditions

Esophagogastroduodenoscopy

Interventions

Computer-aided Real-time Automatic Quality-control SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Mean inspection completeness of two groups.

Inspection completeness includes taking standard images of each parts of esophageal and gastric cavity.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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