Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

Not Applicable

Completed

• Conditions: Esophagogastroduodenoscopy
• Interventions: Other: automatic quality-control system

• Registration Number: NCT03883035
• Lead Sponsor: Yanqing Li

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.

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-19
• Study Start: 2019-03-20
• Study First Posted: 2019-03-20
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1060

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EAS-aided group	automatic quality-control system	esophagogastroduodenoscopy examination with the assistance of automatic quality-control system

Primary Outcome Measures

Name	Time	Method
detection rate of gastric neoplasms	8 months	detection rate of gastric neoplasms in different groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China