ClinicalTrials.gg
CompletedNCT03883035Updated Jan 30, 2020

Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

An interventional study of automatic quality-control system in Esophagogastroduodenoscopy, sponsored by Yanqing Li. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Yanqing Li · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,060
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,180 studies in Stomach Neoplasms with a site in China — 479 open to participants now, 553 under way, 50 of them phase 3. Stomach Neoplasms · China.

Enrollment
30th of 878
1,060 · median 88
Started
2019
with 59 others
No phase
221 of 1,180
95 open now
Registered
376th of 1,180
by date

Among the 1,180 studies in Stomach Neoplasms with a site in China, this one is the 30th largest by enrollment of the 878 interventional ones that give a count, is one of 60 that started in 2019, is one of 221 with no phase, and was the 376th registered.

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

479 of the 1,180 studies in Stomach Neoplasms with a site in China are open now. Recruiting first, the newest first:

474 more — sign in →

All 479 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 702 Stomach Neoplasms studies recruiting now, 375 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 68 take healthy volunteers.

This study: 40 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Esophagogastroduodenoscopy

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Keywords

  • Esophagogastroduodenoscopy
  • gastric neoplasm
  • artificial intelligence
  • quality control
04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients undergoing EGD examination with anaesthesia;
  • patients able to give .

Exclusion criteria

Exclusion Criteria:

  • patients with the 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
1,060 participants (actual)

Study arms

  • Experimental
    EAS-aided group

    esophagogastroduodenoscopy examination with the assistance of automatic quality-control system

    Other: automatic quality-control system

  • No intervention
    control group

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

Interventions

  • Otherautomatic quality-control system

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

06

What researchers measure

Primary outcomes

  1. detection rate of gastric neoplasms

    detection rate of gastric neoplasms in different groups

    Time frame: 8 months

Secondary outcomes

  1. mean number of gastric neoplasms detected

    mean number of gastric neoplasms detected per procedure in different groups

    Time frame: 8 months

  2. mean inspection completeness

    inspection completeness per procedure in different groups

    Time frame: 8 months

  3. mean inspection time

    inspection time per procedure in different groups

    Time frame: 8 months

  4. errors of EAS

    errors of EAS in EAS-aided group

    Time frame: 8 months

07

Study locations

1 site
  • Department of Gastroenterology, Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2019 to primary completion in Oct 2019, 7 months.

Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's 7 months is below that.

Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2019
First posted
Mar 20, 2019
StartActual
Mar 20, 2019
Primary completionActual
Oct 31, 2019
CompletionActual
Oct 31, 2019
Last update
Jan 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03883035
Lead sponsor
Yanqing Li
Responsible party
Yanqing Li (vice president of Qilu Hospital, Shandong University) — Sponsor-investigator
First posted
Mar 20, 2019
Start date
Mar 20, 2019
Primary completion
Oct 31, 2019
Completion
Oct 31, 2019
Last update
Jan 30, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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