Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

NCT ID: NCT03883035

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2019-10-31

Brief Summary

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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

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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

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Esophagogastroduodenoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EAS-aided group

esophagogastroduodenoscopy examination with the assistance of automatic quality-control system

Group Type EXPERIMENTAL

automatic quality-control system

Intervention Type OTHER

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

control group

conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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automatic quality-control system

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yanqing Li

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

vice president of Qilu Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2019SDU-QILU-02

Identifier Type: -

Identifier Source: org_study_id

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