EsophagogastroduodenoscopyNCT04720924
AQCS for Detection of Early Cancer and Precancerous Lesions on Upper Gastrointestinal Tract
A study of Esophagogastroduodenoscopy, run by Shandong University at 6 sites in China.
Trial summary
The purpose of our study was to assess the performance of esophagogastroduodenoscopy automatic quality-control system in real-time quality control of EGD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Esophagogastroduodenoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,840 participants
- Where
- 6 sitesChina
- Study dates
- 16 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40-80 years old
- Patients scheduled for white light EGD examination with anaesthesia
- American Society of Anesthesiology risk class 1, 2 or 3
Who cannot join
- Patients with known advanced esophageal or gastric cancer
- Patients with a history of esophageal or gastric surgery
- Patients scheduled for therapeutic EGD
- Patients with stenosis or obstruction of upper gastrointestinal tract
- Patients with a history of serious anesthesia-related complications
- Patients in pregnancy or lactation phase
- Patients refused to sign the informed consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Binzhou Medical University Hospital
Binzhou, Shandong
Linyi People's Hospital
Dezhou, Shandong
Central Hospital of Shengli Oilfield
Dongying, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
PKUcare Luzhong Hospital
Zibo, Shandong
Zibo Municipal Hospital
Zibo, Shandong
About this study
Official title: Computer-aided Real-time Automatic Quality-control System for Detection of Early Cancer and Precancerous Lesions on Upper Gastrointestinal Tract: a Multicenter Randomized Controlled Study
The purpose of our study was to assess the performance of esophagogastroduodenoscopy automatic quality-control system in real-time quality control of EGD.
Read the detailed description
Investigators developed a real-time quality control system of esophagogastroduodenoscopy(EGD) named EGD automatic quality-control system (AQCS). Investigators carried a prospective multicenter randomized controlled trial to assess the performance of this system in quality control of real-time EGD, including detecting the early upper gastrointestinal cancer and precancerous lesions, assessing inspection completeness, mucosal visibility, time of EGD procedure and other indicators.
- Conditions
- Esophagogastroduodenoscopy
- Being tested
- Computer-aided Real-time Automatic Quality-control System
- Keywords
- Esophagogastroduodenoscopy, Gastric Cancer, esophageal cancer, Artificial Intelligence, Quality-control
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-aided Real-time Automatic Quality-control SystemDevice
EGD automatic quality-control system(AQCS),developed based on deep convolutional neural network (DCNN) models,could facilitate real-time detection of upper gastrointestinal lesions, assess inspection completeness and mucosal visibility, and calculate time of EGD procedure.
| Study group | Role | What they receive |
|---|---|---|
| AQCS-aided group | Experimental | Patients in AQCS-aided group will go through white light EGD examination with assistance of AQCS. Receives: Device: Computer-aided Real-time Automatic Quality-control System |
| Control group | No intervention | Patients in control group will go through white light EGD examination without AQCS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination
The primary outcome is the detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination per group.
Measured: 6 months
Secondary outcomes (4)
Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract in tertiary hospitals and secondary hospitals.
Effect of detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from tertiary hospitals and secondary hospitals with assistance of AQCS.
Measured: 6 months
Mean inspection completeness of two groups.
Inspection completeness includes taking standard images of each parts of esophageal and gastric cavity.
Measured: 6 months
Mean inspection time of EGD procedure of two groups.
Inspection time of EGD procedure is the time endoscopy inserting to withdrawing the mouth and does not include the time of biopsy.
Measured: During procedure
Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS.
Effect of detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start16 Jan 2021
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EsophagogastroduodenoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Binzhou Medical University, Shengli Oilfield Hospital, Peking University Care Luzhong Hospital, Linyi People's Hospital, Zibo Municipal Hospital
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720924
- Sponsor's protocol ID
- 2020SDU-QILU-1022
- Status last verified
- May 2024
- First submitted
- 17 Jan 2021
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou R, Liu J, Zhang C, Zhao Y, Su J, Niu Q, Liu C, Guo Z, Cui Z, Zhong X, Zhao W, Li J, Zhang X, Wang H, Sun S, Ma R, Chen X, Xu X, Zhu Y, Li Z, Zuo X, Li Y. Efficacy of a real-time intelligent quality-control system for the detection of early upper gastrointestinal neoplasms: a multicentre, single-blinded, randomised controlled trial. EClinicalMedicine. 2024 Aug 30;75:102803. doi: 10.1016/j.eclinm.2024.102803. eCollection 2024 Sep.
PubMed 39281103
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-aided Real-time Automatic Quality-control System for Detection of Early Cancer and Precancerous Lesions on Upper Gastrointestinal Tract: a Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04720924
- Acronym / sponsor ID
- 2020SDU-QILU-1022
- Conditions
- Esophagogastroduodenoscopy
- Keywords
- Esophagogastroduodenoscopy, Gastric Cancer, esophageal cancer, Artificial Intelligence, Quality-control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,840 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Binzhou Medical University, Shengli Oilfield Hospital, Peking University Care Luzhong Hospital, Linyi People's Hospital, Zibo Municipal Hospital
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our study was to assess the performance of esophagogastroduodenoscopy automatic quality-control system in real-time quality control of EGD.
Detailed description
Investigators developed a real-time quality control system of esophagogastroduodenoscopy(EGD) named EGD automatic quality-control system (AQCS). Investigators carried a prospective multicenter randomized controlled trial to assess the performance of this system in quality control of real-time EGD, including detecting the early upper gastrointestinal cancer and precancerous lesions, assessing inspection completeness, mucosal visibility, time of EGD procedure and other indicators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AQCS-aided group | Experimental | Device: Computer-aided Real-time Automatic Quality-control SystemPatients in AQCS-aided group will go through white light EGD examination with assistance of AQCS. |
| Control group | No intervention | –Patients in control group will go through white light EGD examination without AQCS. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 40-80 years old
- Patients scheduled for white light EGD examination with anaesthesia
- American Society of Anesthesiology risk class 1, 2 or 3
Key exclusion criteria (7 listed)
- Patients with known advanced esophageal or gastric cancer
- Patients with a history of esophageal or gastric surgery
- Patients scheduled for therapeutic EGD
- Patients with stenosis or obstruction of upper gastrointestinal tract
- Patients with a history of serious anesthesia-related complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-aided Real-time Automatic Quality-control SystemEGD automatic quality-control system(AQCS),developed based on deep convolutional neural network (DCNN) models,could facilitate real-time detection of upper gastrointestinal lesions, assess inspection completeness and mucosal visibility, and calculate time of EGD procedure. | Device | AQCS-aided group |
Primary outcome
Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination
Time frame: 6 months
The primary outcome is the detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination per group.
4 secondary outcomes
Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract in tertiary hospitals and secondary hospitals.
Time frame: 6 months
Mean inspection completeness of two groups.
Time frame: 6 months
Mean inspection time of EGD procedure of two groups.
Time frame: During procedure
Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract from senior, intermediate and primary endoscopist with assistance of AQCS.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 39281103Zhou R, Liu J, Zhang C, Zhao Y, Su J, Niu Q, Liu C, Guo Z, Cui Z, Zhong X, Zhao W, Li J, Zhang X, Wang H, Sun S, Ma R, Chen X, Xu X, Zhu Y, Li Z, Zuo X, Li Y. Efficacy of a real-time intelligent quality-control system for the detection of early upper gastrointestinal neoplasms: a multicentre, single-blinded, randomised controlled trial. EClinicalMedicine. 2024 Aug 30;75:102803. doi: 10.1016/j.eclinm.2024.102803. eCollection 2024 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li, PhD study chair
Qilu Hospital of Shandong University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Esophagogastroduodenoscopy, run by Shandong University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of early cancer and precancerous lesions on upper gastrointestinal tract confirmed by pathological examination (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04720924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.