Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

Esophagogastroduodenoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883035
• Other study ID #: 2019SDU-QILU-02
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: January 2020
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1060
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophagogastroduodenoscopy

Intervention

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

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yanqing Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection rate of gastric neoplasms	detection rate of gastric neoplasms in different groups	8 months
Secondary	mean number of gastric neoplasms detected	mean number of gastric neoplasms detected per procedure in different groups	8 months
Secondary	mean inspection completeness	inspection completeness per procedure in different groups	8 months
Secondary	mean inspection time	inspection time per procedure in different groups	8 months
Secondary	errors of EAS	errors of EAS in EAS-aided group	8 months