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

Sponsor

Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04720924

Collaborator

Binzhou Medical University (Other), Central Hospital of Shengli Oilfield (Other), Peking University Care Luzhong Hospital (Other), Linyi People's Hospital (Other), Zibo municipal hospital (Other)

1,840

Enrollment

Locations

Arms

11.4

Anticipated Duration (Months)

306.7

Patients Per Site

26.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jan 16, 2021

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination [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

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

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Binzhou Medical University Hospital	Binzhou	Shandong	China
2	Linyi People's Hospital	Dezhou	Shandong	China
3	Central Hospital of Shengli Oilfield	Dongying	Shandong	China
4	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012
5	PKUcare Luzhong Hospital	Zibo	Shandong	China
6	Zibo Municipal Hospital	Zibo	Shandong	China