NCT04720924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

January 17, 2021

Last Update Submit

May 25, 2024

Conditions

Esophagogastroduodenoscopy

Keywords

EsophagogastroduodenoscopyGastric Canceresophageal cancerArtificial IntelligenceQuality-control

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (4)

  • Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract in tertiary hospitals and secondary hospitals.

    6 months

  • Mean inspection completeness of two groups.

    6 months

  • Mean inspection time of EGD procedure of two groups.

    During procedure

  • Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS.

    6 months

Study Arms (2)

AQCS-aided group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

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.

AQCS-aided group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Binzhou Medical University Hospital

Binzhou, Shandong, China

Location

Linyi People's Hospital

Dezhou, Shandong, China

Location

Central Hospital of Shengli Oilfield

Dongying, Shandong, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

PKUcare Luzhong Hospital

Zibo, Shandong, China

Location

Zibo Municipal Hospital

Zibo, Shandong, China

Location

Related Publications (1)

  • 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.

    PMID: 39281103DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Officials

  • Yanqing Li, PhD

    Qilu Hospital of Shandong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

January 17, 2021

First Posted

January 22, 2021

Study Start

January 16, 2021

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

CN(6)