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Completed

NCT Number: NCT03883035

Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

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.

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Key information

Conditions

Esophagogastroduodenoscopy Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

automatic quality-control system

Other

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

Primary outcomes

  1. detection rate of gastric neoplasms

    Time frame: 8 months

    detection rate of gastric neoplasms in different groups

Secondary outcomes

  1. mean number of gastric neoplasms detected

    Time frame: 8 months

    mean number of gastric neoplasms detected per procedure in different groups

  2. mean inspection completeness

    Time frame: 8 months

    inspection completeness per procedure in different groups

  3. mean inspection time

    Time frame: 8 months

    inspection time per procedure in different groups

  4. errors of EAS

    Time frame: 8 months

    errors of EAS in EAS-aided group

Sponsors and collaborators

Lead sponsor

Yanqing Li

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2019
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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