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

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ClinicalTrials.gov Identifier: NCT04720924
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
Binzhou Medical University
Central Hospital of Shengli Oilfield
PKUcare luzhong hospital
Linyi People's Hospital
Zibo municipal hospital
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophagogastroduodenoscopy Device: Computer-aided Real-time Automatic Quality-control System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : January 16, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Mean inspection completeness of two groups. [ Time Frame: 6 months ]
    Inspection completeness includes taking standard images of each parts of esophageal and gastric cavity.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720924


Contacts
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Contact: Zhen Li, PhD 18560086106 lizhenh@hotmail.com
Contact: Ruchen Zhou, MD 15949702165 sdlwzrc@126.com

Locations
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China, Shandong
Binzhou Medical University Hospital Recruiting
Binzhou, Shandong, China
Contact: Qiong Niu         
Linyi People's Hospital Recruiting
Dezhou, Shandong, China
Contact: Xiaodong Zhang         
Central Hospital of Shengli Oilfield Recruiting
Dongying, Shandong, China
Contact: Zhenqin Cui         
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li         
PKUcare Luzhong Hospital Recruiting
Zibo, Shandong, China
Contact: Shidong Sun         
Zibo Municipal Hospital Recruiting
Zibo, Shandong, China
Contact: Weidong Zhao         
Sponsors and Collaborators
Shandong University
Binzhou Medical University
Central Hospital of Shengli Oilfield
PKUcare luzhong hospital
Linyi People's Hospital
Zibo municipal hospital
Investigators
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Study Chair: Yanqing Li, PhD Qilu Hospital of Shandong University
More Information
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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT04720924    
Other Study ID Numbers: 2020SDU-QILU-1022
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanqing Li, Shandong University:
Esophagogastroduodenoscopy
Gastric Cancer
esophageal cancer
Artificial Intelligence
Quality-control