Gastrointestinal DiseaseNCT04275609
The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
A study testing AI generated report and physicians writing report in people with Gastrointestinal Disease, run by Shandong University.
Trial summary
The purpose of this study is to compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disease
- What is being tested?
- AI generated report and physicians writing report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2020to 30 Mar 2020
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged between 18 and 80 years；
- patients undergoing gastroscopy and colonoscopy examination with anesthesia；
- patients able to give informed consent
Who cannot join
- patients with the contraindications to endoscopic examination;
- a history of gastrointestinal cancers;
- allergic to anaesthetics in previous medical history;
- the endoscopic procedure cannot be completed due to stenosis, obstruction, solid food or complications of anaesthesia.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.
Read the detailed description
Digestive endoscopy permits early detection of gastrointestinal diseases and improving the patients' quality of life. However, writing endoscopic report takes a lot of manpower and time, reducing the efficiency of endoscopy. Our center has developed a structured diagnostic report generation system for digestive endoscopy, which can generates the report by artificial intelligence. Here, we compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.
- Conditions
- Gastrointestinal Disease
- Being tested
- AI generated report, physicians writing report
- Keywords
- Endoscopic Report, Artificial Intelligence, Gastrointestinal Disease, Writing Efficiency
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI generated reportOther
After the endoscopic procedure, the physicians click the structured reporting button of computer to automatically complete the report through the structured diagnostic report generation system. The physicians only make minor corrections to the report.
physicians writing reportOther
After the endoscopic procedure, the physicians writing the report in computer according the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Artificial Intelligence generating endoscopic report | Experimental | In this group, the endoscopic report was generated by artificial intelligence (AI) based on the structured diagnostic report generation system. Receives: Other: AI generated report |
| Physicians writing endoscopic report | Active comparator | In this group, the endoscopic report was writing by physicians. Receives: Other: physicians writing report |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time spent writing reports
Sum of the time for writing gastroscopic report and colonoscopic report。
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start20 Feb 2020 (estimated)
- Primary completion20 Mar 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275609
- Sponsor's protocol ID
- 2020SDU-QILU-G002
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04275609
- Acronym / sponsor ID
- 2020SDU-QILU-G002
- Conditions
- Gastrointestinal Disease
- Keywords
- Endoscopic Report, Artificial Intelligence, Gastrointestinal Disease, Writing Efficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 19 Feb 2020 (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 this study is to compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.
Detailed description
Digestive endoscopy permits early detection of gastrointestinal diseases and improving the patients' quality of life. However, writing endoscopic report takes a lot of manpower and time, reducing the efficiency of endoscopy. Our center has developed a structured diagnostic report generation system for digestive endoscopy, which can generates the report by artificial intelligence. Here, we compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence generating endoscopic report | Experimental | Other: AI generated reportIn this group, the endoscopic report was generated by artificial intelligence (AI) based on the structured diagnostic report generation system. |
| Physicians writing endoscopic report | Active comparator | Other: physicians writing reportIn this group, the endoscopic report was writing by physicians. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged between 18 and 80 years；
- patients undergoing gastroscopy and colonoscopy examination with anesthesia；
- patients able to give informed consent
Key exclusion criteria (4 listed)
- patients with the contraindications to endoscopic examination;
- a history of gastrointestinal cancers;
- allergic to anaesthetics in previous medical history;
- the endoscopic procedure cannot be completed due to stenosis, obstruction, solid food or complications of anaesthesia.
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 |
|---|---|---|
| AI generated reportAfter the endoscopic procedure, the physicians click the structured reporting button of computer to automatically complete the report through the structured diagnostic report generation system. The physicians only make minor corrections to the report. | Other | Artificial Intelligence generating endoscopic report |
| physicians writing reportAfter the endoscopic procedure, the physicians writing the report in computer according the procedure. | Other | Physicians writing endoscopic report |
Primary outcome
The time spent writing reports
Time frame: Intraoperative
Sum of the time for writing gastroscopic report and colonoscopic report。
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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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.
Xiuli Zuo, MD,PhD principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A study testing AI generated report and physicians writing report in people with Gastrointestinal Disease, run by Shandong University.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zuo, MD,PhD (15588818685, zuoxiuli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time spent writing reports (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2020.