CompletedNCT03883035Updated Jan 30, 2020

Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

An interventional study of automatic quality-control system in Esophagogastroduodenoscopy, sponsored by Yanqing Li. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Yanqing Li · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 1,060
Allocation: Randomized
Ages: 40 Years to 80 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Esophagogastroduodenoscopy

Browse trials for

Stomach Neoplasms 2,842

Keywords

Esophagogastroduodenoscopy
gastric neoplasm
artificial intelligence
quality control

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 1,060 participants (actual)

Study arms

Experimental
EAS-aided group
esophagogastroduodenoscopy examination with the assistance of automatic quality-control system
Other: automatic quality-control system
No intervention
control group
conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system

Interventions

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

What researchers measure

Primary outcomes

detection rate of gastric neoplasms
detection rate of gastric neoplasms in different groups
Time frame: 8 months

Secondary outcomes

mean number of gastric neoplasms detected
mean number of gastric neoplasms detected per procedure in different groups
Time frame: 8 months
mean inspection completeness
inspection completeness per procedure in different groups
Time frame: 8 months
mean inspection time
inspection time per procedure in different groups
Time frame: 8 months
errors of EAS
errors of EAS in EAS-aided group
Time frame: 8 months

Study locations

1 site

Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong 250012, China

Registry details

Key details

Study ID: NCT03883035
Lead sponsor: Yanqing Li
Responsible party: Yanqing Li (vice president of Qilu Hospital, Shandong University) — Sponsor-investigator
First posted: Mar 20, 2019
Start date: Mar 20, 2019
Primary completion: Oct 31, 2019
Completion: Oct 31, 2019
Last update: Jan 30, 2020

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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