Clinical trial NCT04720924: AQCS for Detection of Early Cancer and Precancerous Lesions on Upper Gastrointestinal Tract
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagogastroduodenoscopy
Keywords: Esophagogastroduodenoscopy
Gastric Cancer
esophageal cancer
Artificial Intelligence
Quality-control
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Binzhou Medical University
name: Shengli Oilfield Hospital
name: Peking University Care Luzhong Hospital
name: Linyi People's Hospital
name: Zibo Central Hospital
First posted: 2021-01-22
Enrollment: 1840
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination
timeFrame: 6 months
Secondary outcomes:
measure: Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract in tertiary hospitals and secondary hospitals.
timeFrame: 6 months
measure: Mean inspection completeness of two groups.
timeFrame: 6 months
measure: Mean inspection time of EGD procedure of two groups.
timeFrame: During procedure
measure: Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS.
timeFrame: 6 months
Other outcomes:
Locations:
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Dezhou
country: China
facility: Linyi People's Hospital
state: Shandong
city: Dongying
country: China
facility: Central Hospital of Shengli Oilfield
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Zibo
country: China
facility: PKUcare Luzhong Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, PhD
role: STUDY_CHAIR
References: