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

Shandong University

Status: Completed

Conditions: Esophagogastroduodenoscopy

Treatments: Device: Computer-aided Real-time Automatic Quality-control System

Study type: Interventional

Funder types: Other

Identifiers

NCT04720924

2020SDU-QILU-1022

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,840 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,840 participants in 2 patient groups

AQCS-aided group

Experimental group

Description:

Patients in AQCS-aided group will go through white light EGD examination with assistance of AQCS.

Treatment:

Device: Computer-aided Real-time Automatic Quality-control System

Control group

No Intervention group

Description:

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