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Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03883035
Enrollment
1060
Registered
2019-03-20
Start date
2019-03-20
Completion date
2019-10-31
Last updated
2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagogastroduodenoscopy

Keywords

Esophagogastroduodenoscopy, gastric neoplasm, artificial intelligence, quality control

Brief summary

The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.

Detailed description

In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.

Interventions

OTHERautomatic quality-control system

Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.

Sponsors

Yanqing Li
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patients undergoing EGD examination with anaesthesia; * patients able to give informed consent.

Exclusion criteria

* patients with the contraindications to EGD examination; * patients with a prior EGD examination within 1 year before the trial; * patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy; * a history of upper gastrointestinal cancers; * allergic to anaesthetic in previous medical history; * patients refused to participate in the trial; * the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.

Design outcomes

Primary

MeasureTime frameDescription
detection rate of gastric neoplasms8 monthsdetection rate of gastric neoplasms in different groups

Secondary

MeasureTime frameDescription
mean number of gastric neoplasms detected8 monthsmean number of gastric neoplasms detected per procedure in different groups
mean inspection completeness8 monthsinspection completeness per procedure in different groups
mean inspection time8 monthsinspection time per procedure in different groups
errors of EAS8 monthserrors of EAS in EAS-aided group

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026