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

May 25, 2024 updated by: Yanqing Li, Shandong University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Binzhou, Shandong, China
        • Binzhou Medical University Hospital
      • Dezhou, Shandong, China
        • Linyi People's Hospital
      • Dongying, Shandong, China
        • Central Hospital of Shengli Oilfield
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
      • Zibo, Shandong, China
        • PKUcare Luzhong Hospital
      • Zibo, Shandong, China
        • Zibo Municipal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AQCS-aided group
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
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.
No Intervention: Control group
Patients in control group will go through white light EGD examination without AQCS.

What is the study measuring?

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
Time Frame: 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.
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.
Time Frame: 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.
6 months
Mean inspection completeness of two groups.
Time Frame: 6 months
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.
Time Frame: During procedure
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.
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Linyi People's Hospital
Peking University Care Luzhong Hospital
Binzhou Medical University
Central Hospital of Shengli Oilfield
Zibo Municipal Hospital

Investigators

  • Study Chair: Yanqing Li, PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 17, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 25, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020SDU-QILU-1022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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