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

NCT ID: NCT04720924

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2023-12-31

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.

Conditions

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Esophagogastroduodenoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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AQCS-aided group

Patients in AQCS-aided group will go through white light EGD examination with assistance of AQCS.

Group Type EXPERIMENTAL

Computer-aided Real-time Automatic Quality-control System

Intervention Type DEVICE

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.

Control group

Patients in control group will go through white light EGD examination without AQCS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Computer-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.

Intervention Type DEVICE

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Binzhou Medical University

OTHER

Sponsor Role collaborator

Shengli Oilfield Hospital

OTHER

Sponsor Role collaborator

Peking University Care Luzhong Hospital

OTHER

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Zibo Municipal Hospital

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Locations

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Binzhou Medical University Hospital

Binzhou, Shandong, China

Site Status

Linyi People's Hospital

Dezhou, Shandong, China

Site Status

Central Hospital of Shengli Oilfield

Dongying, Shandong, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

PKUcare Luzhong Hospital

Zibo, Shandong, China

Site Status

Zibo Municipal Hospital

Zibo, Shandong, China

Site Status

Countries

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China

References

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Zhou R, Liu J, Zhang C, Zhao Y, Su J, Niu Q, Liu C, Guo Z, Cui Z, Zhong X, Zhao W, Li J, Zhang X, Wang H, Sun S, Ma R, Chen X, Xu X, Zhu Y, Li Z, Zuo X, Li Y. Efficacy of a real-time intelligent quality-control system for the detection of early upper gastrointestinal neoplasms: a multicentre, single-blinded, randomised controlled trial. EClinicalMedicine. 2024 Aug 30;75:102803. doi: 10.1016/j.eclinm.2024.102803. eCollection 2024 Sep.

Reference Type DERIVED
PMID: 39281103 (View on PubMed)

Other Identifiers

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2020SDU-QILU-1022

Identifier Type: -

Identifier Source: org_study_id

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