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

Esophagogastroduodenoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720924
• Other study ID #: 2020SDU-QILU-1022
• Status: Completed
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1840
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagogastroduodenoscopy

Intervention

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.

Locations

Country	Name	City	State
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Linyi People's Hospital	Dezhou	Shandong
China	Central Hospital of Shengli Oilfield	Dongying	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	PKUcare Luzhong Hospital	Zibo	Shandong
China	Zibo Municipal Hospital	Zibo	Shandong

Sponsors (6)

Lead Sponsor	Collaborator
Shandong University	Binzhou Medical University, Central Hospital of Shengli Oilfield, Linyi People's Hospital, Peking University Care Luzhong Hospital, Zibo municipal hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract in tertiary hospitals and secondary hospitals.	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
Secondary	Mean inspection completeness of two groups.	Inspection completeness includes taking standard images of each parts of esophageal and gastric cavity.	6 months
Secondary	Mean inspection time of EGD procedure of two groups.	Inspection time of EGD procedure is the time endoscopy inserting to withdrawing the mouth and does not include the time of biopsy.	During procedure
Secondary	Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS.	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