Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

• Sponsor: Yanqing Li (Other)
• Overall Status: Completed
• CT.gov ID: NCT03883035
• Collaborator: (none)
• Enrollment: 1,060
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.4
• Patients Per Site Per Month: 143.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophagogastroduodenoscopy	Other: automatic quality-control system	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1060 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms
• Actual Study Start Date: Mar 20, 2019
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EAS-aided group esophagogastroduodenoscopy examination with the assistance of automatic quality-control system	Other: automatic quality-control system; Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.
No Intervention: control group conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system

Outcome Measures

Primary Outcome Measures

1. detection rate of gastric neoplasms [8 months]

   detection rate of gastric neoplasms in different groups

Secondary Outcome Measures

1. mean number of gastric neoplasms detected [8 months]

   mean number of gastric neoplasms detected per procedure in different groups

2. mean inspection completeness [8 months]

   inspection completeness per procedure in different groups

3. mean inspection time [8 months]

   inspection time per procedure in different groups

4. errors of EAS [8 months]

   errors of EAS in EAS-aided group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

• Yanqing Li

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanqing Li, vice president of Qilu Hospital, Shandong University
• ClinicalTrials.gov Identifier: NCT03883035
• Other Study ID Numbers: 2019SDU-QILU-02
• First Posted: Mar 20, 2019
• Last Update Posted: Jan 30, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yanqing Li, vice president of Qilu Hospital, Shandong University: Esophagogastroduodenoscopy; gastric neoplasm; artificial intelligence; quality control

Study Results

No Results Posted as of Jan 30, 2020