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Completed

NCT Number: NCT04720924

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

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

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Key information

Conditions

Esophagogastroduodenoscopy Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binzhou Medical University Hospital, Binzhou, Shandong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-aided Real-time Automatic Quality-control System

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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