Endoscopy, Digestive SystemNCT05845463
The Impact of Artificial Intelligence (AI) on the Quality of Upper Gastrointestinal (GI) Endoscopy
A study of Endoscopy, Digestive System, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Oesophageal and gastric cancer are two of the six less survivable cancers, responsible for half of cancer deaths and a quarter of cancer cases. Six cancer charities have called for focused efforts to improve the poor outcomes for these cancers that have changed little in recent years (lesssurvivablecancers.org.uk). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopy, Digestive System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2023to 1 Jun 2025
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 18 years of age or above who are scheduled for outpatient diagnostic UGI endoscopy will be invited to part take in the study.
Who cannot join
- The following subjects will be excluded from the study:
- Inpatient/ emergency OGD referrals
- Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion),
- Previous gastro-duodenal surgery
- Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)
Trial locations and contacts
1 site in 1 country.
Nigel Trudgill, MbChB contact
United Kingdom1 site
Sandwell General Hospital
Birmingham, West Midlands, B71 4HJ
Kelly Hard, kellyhard@nhs.net
Amar Srinivasa, MBBS
About this study
Oesophageal and gastric cancer are two of the six less survivable cancers, responsible for half of cancer deaths and a quarter of cancer cases. Six cancer charities have called for focused efforts to improve the poor outcomes for these cancers that have changed little in recent years (lesssurvivablecancers.org.uk). Improving endoscopy standards to minimise missed cancer cases will be an important contribution to improving oesophageal and gastric cancer outcomes.
Endoscopy, flexible telescopic examination of the oesophagus, stomach and duodenum, is the method of choice for diagnosing upper gastrointestinal (UGI) cancer and its main purpose is usually to exclude cancer as the cause of peoples' symptoms. Over 1,000,000 endoscopies are undertaken each year in the UK but the test is not perfect and sometimes cancer or an abnormality that will turn into cancer is not found. When this happens, the cancer is known as a post-endoscopy upper gastrointestinal cancer (PEUGIC) or a 'missed' cancer. This is unfortunately a relatively common occurrence and 9% of people with UGI cancer in the UK (approximately 1400 per year) had an endoscopy that did not find their cancer in the three years before diagnosis.
Read more
All people who undergo endoscopy will benefit from this research. Reducing the future number of cancers that are missed at endoscopy in England will be a direct benefit but preventing missed cancers will also help to improve the general quality of endoscopy.
The rate of missing cancer at colonoscopy (post-colonoscopy colorectal cancer) has fallen from 9% in 2005 to 6.5% in 2013, unlike the PEUGIC rate that has increased between 2009 and 2018. Research has shown that endoscopists with longer procedure times and those who take more than four pictures during endoscopy have a higher abnormality detection rate for early cancer.
In an attempt to help endoscopists, a novel AI called Cerebro has been developed as an endoscopy quality control tool. Cerebro gives the endoscopist real time feedback during an endoscopy, and aids them in the four following areas (Endovision AI 2022)
- Ensures inspection completeness prompting the endoscopist on which areas have been missed.
- Calculates the time spent at each landmark ensuring at least a 7-minute examination time.
- Provides automatic photodocumentation which allows for better reporting
- Prompts the endoscopist when further insufflation or washing is needed to improve views Variation in endoscopy quality in the UK will contribute to variations in missed cancer frequency and efforts to improve endoscopy quality, including using AI to standardise endoscopy quality, will hopefully reduce the frequency of PEUGIC in future and improve upper GI cancer outcomes. However, in order for AI use in endoscopy to be established its value in improving the quality of views needs studying.
Read the detailed description
Study design The research team propose to carry out a randomised crossover trial to assess the impact of AI on the quality of upper GI endoscopy Primary objective Quantifying the improvement that AI provides for a diagnostic endoscopy Primary Endpoint Number of sites successfully inspected during endoscopy (0-28) Secondary Endpoints Overall procedure time Individual site inspection time (0-28)
Hypothesis The research team hypothesize that with the use of AI the number of sites successfully inspected during endoscopy will be increased and as a result there will be an increase in the overall procedure time and individual site inspection time.
Plan An Artificial intelligence endoscopy quality control tool has been developed called Cerebro (Endovision, Hong Kong). Cerebro has been developed and validated in Hong Kong and Singapore but not previously used elsewhere in the world.
Validation phase Although the AI has been validated in the Far East, there have been no validation studies carried out in the West. The research team will record 30 endoscopy videos for the AI to analyse to provide a score for completeness for the procedure. The same videos will be viewed by a panel of endoscopy experts to see if they are in agreement with the AIs completeness score for the procedure. All videos will be anonymised.
Work phase one The research team plan to use Cerebro initially to assess the quality of endoscopy in independent and trainee endoscopists in the UK in a cross-sectional study of all endoscopists at Sandwell and West Birmingham NHS trust (SWBH) by recording participants success at examining all areas of the upper GI tract during diagnostic endoscopy as assessed by Cerebro in at least ten endoscopies, without providing feedback from Cerebro to the endoscopist during endoscopy at this stage. This analysis will provide data on the quality of endoscopy and particular areas of the upper GI tract that are not well examined in Western endoscopic practice that may contribute to missed cancer (PEUGIC).
Work phase two Will involve participants undergoing diagnostic endoscopy at Sandwell and West Birmingham NHS trust (SWBH).
We would then plan a randomised cross-over trial of Cerebro among all available endoscopists at SWBH. Following a period where Cerebro is used to assess endoscopists' baseline performance during at least 10 endoscopies without providing feedback to the endoscopists, the endoscopists of varying levels of experience and specialty will be randomised to receive feedback from Cerebro during all endoscopies or have Cerebro continue to record endoscopy view quality but not feedback to the endoscopist for three months. The two groups will then be crossed over.
The learning curve to improve endoscopy view quality and sustainability of improvements in the absence of real-time feedback from Cerebro will then be assessed.
Study population Inclusion criteria Subjects 18 years of age or above who are scheduled for outpatient diagnostic UGI endoscopy will be invited to part take in the study.
Exclusion criteria The following subjects will be excluded from the study: inpatient/ emergency OGD referrals, referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion), previous gastro-duodenal surgery, any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease) or any major medical or neoplastic co-morbidity.
Estimated duration 24 months
- Conditions
- Endoscopy, Digestive System
- Being tested
- Cerebro endoscopy quality control tool
- Keywords
- Endoscopy, Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebro endoscopy quality control toolDevice
The AI provides feedback via a separate screen to the endoscopists to inform them which part of the upper GI tract have been adequately visualised.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopists with AI feedback | Experimental | This will be the group of endoscopists who will have AI feedback during the endoscopy Receives: Device: Cerebro endoscopy quality control tool |
| Endoscopists without AI feedback | Active comparator | This will be the group of endoscopists without AI feedback during the endoscopy to assess their baseline site detection rate. Both arms will cross over to see if AI improves endoscopy quality and if its removal decreases quality. Receives: Device: Cerebro endoscopy quality control tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sites successfully inspected during endoscopy (0-28)
Number of sites successfully inspected during endoscopy (0-28)
Measured: During time of endoscopy
Secondary outcomes (2)
Overall procedure time
Endoscopy procedure time
Measured: During time of endoscopy
Individual site inspection time
Time spent at each area of the digestive tract
Measured: During time of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopy, Digestive SystemStudies 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
- Crossover
- Model description
- The research team propose to carry out a randomised crossover trial to assess the impact of AI on the quality of upper GI endoscopy
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigel Trudgill, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Nigel Trudgill, MbChB, Principal investigator, Sandwell General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845463
- Sponsor's protocol ID
- V0.1
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be anonymised and only aggregated data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Artificial Intelligence (AI) on the Quality of Upper Gastrointestinal (GI) Endoscopy
- ClinicalTrials.gov ID
- NCT05845463
- Acronym / sponsor ID
- V0.1
- Conditions
- Endoscopy, Digestive System
- Keywords
- Endoscopy, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 6 May 2023 (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.
Oesophageal and gastric cancer are two of the six less survivable cancers, responsible for half of cancer deaths and a quarter of cancer cases. Six cancer charities have called for focused efforts to improve the poor outcomes for these cancers that have changed little in recent years (lesssurvivablecancers.org.uk). Improving endoscopy standards to minimise missed cancer cases will be an important contribution to improving oesophageal and gastric cancer outcomes.
Endoscopy, flexible telescopic examination of the oesophagus, stomach and duodenum, is the method of choice for diagnosing upper gastrointestinal (UGI) cancer and its main purpose is usually to exclude cancer as the cause of peoples' symptoms. Over 1,000,000 endoscopies are undertaken each year in the UK but the test is not perfect and sometimes cancer or an abnormality that will turn into cancer is not found. When this happens, the cancer is known as a post-endoscopy upper gastrointestinal cancer (PEUGIC) or a 'missed' cancer. This is unfortunately a relatively common occurrence and 9% of people with UGI cancer in the UK (approximately 1400 per year) had an endoscopy that did not find their cancer in the three years before diagnosis.
All people who undergo endoscopy will benefit from this research. Reducing the future number of cancers that are missed at endoscopy in England will be a direct benefit but preventing missed cancers will also help to improve the general quality of endoscopy.
The rate of missing cancer at colonoscopy (post-colonoscopy colorectal cancer) has fallen from 9% in 2005 to 6.5% in 2013, unlike the PEUGIC rate that has increased between 2009 and 2018. Research has shown that endoscopists with longer procedure times and those who take more than four pictures during endoscopy have a higher abnormality detection rate for early cancer.
In an attempt to help endoscopists, a novel AI called Cerebro has been developed as an endoscopy quality control tool. Cerebro gives the endoscopist real time feedback during an endoscopy, and aids them in the four following areas (Endovision AI 2022)
- Ensures inspection completeness prompting the endoscopist on which areas have been missed.
- Calculates the time spent at each landmark ensuring at least a 7-minute examination time.
- Provides automatic photodocumentation which allows for better reporting
- Prompts the endoscopist when further insufflation or washing is needed to improve views Variation in endoscopy quality in the UK will contribute to variations in missed cancer frequency and efforts to improve endoscopy quality, including using AI to standardise endoscopy quality, will hopefully reduce the frequency of PEUGIC in future and improve upper GI cancer outcomes. However, in order for AI use in endoscopy to be established its value in improving the quality of views needs studying.
Detailed description
Study design The research team propose to carry out a randomised crossover trial to assess the impact of AI on the quality of upper GI endoscopy Primary objective Quantifying the improvement that AI provides for a diagnostic endoscopy Primary Endpoint Number of sites successfully inspected during endoscopy (0-28) Secondary Endpoints Overall procedure time Individual site inspection time (0-28)
Hypothesis The research team hypothesize that with the use of AI the number of sites successfully inspected during endoscopy will be increased and as a result there will be an increase in the overall procedure time and individual site inspection time.
Plan An Artificial intelligence endoscopy quality control tool has been developed called Cerebro (Endovision, Hong Kong). Cerebro has been developed and validated in Hong Kong and Singapore but not previously used elsewhere in the world.
Validation phase Although the AI has been validated in the Far East, there have been no validation studies carried out in the West. The research team will record 30 endoscopy videos for the AI to analyse to provide a score for completeness for the procedure. The same videos will be viewed by a panel of endoscopy experts to see if they are in agreement with the AIs completeness score for the procedure. All videos will be anonymised.
Work phase one The research team plan to use Cerebro initially to assess the quality of endoscopy in independent and trainee endoscopists in the UK in a cross-sectional study of all endoscopists at Sandwell and West Birmingham NHS trust (SWBH) by recording participants success at examining all areas of the upper GI tract during diagnostic endoscopy as assessed by Cerebro in at least ten endoscopies, without providing feedback from Cerebro to the endoscopist during endoscopy at this stage. This analysis will provide data on the quality of endoscopy and particular areas of the upper GI tract that are not well examined in Western endoscopic practice that may contribute to missed cancer (PEUGIC).
Work phase two Will involve participants undergoing diagnostic endoscopy at Sandwell and West Birmingham NHS trust (SWBH).
We would then plan a randomised cross-over trial of Cerebro among all available endoscopists at SWBH. Following a period where Cerebro is used to assess endoscopists' baseline performance during at least 10 endoscopies without providing feedback to the endoscopists, the endoscopists of varying levels of experience and specialty will be randomised to receive feedback from Cerebro during all endoscopies or have Cerebro continue to record endoscopy view quality but not feedback to the endoscopist for three months. The two groups will then be crossed over.
The learning curve to improve endoscopy view quality and sustainability of improvements in the absence of real-time feedback from Cerebro will then be assessed.
Study population Inclusion criteria Subjects 18 years of age or above who are scheduled for outpatient diagnostic UGI endoscopy will be invited to part take in the study.
Exclusion criteria The following subjects will be excluded from the study: inpatient/ emergency OGD referrals, referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion), previous gastro-duodenal surgery, any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease) or any major medical or neoplastic co-morbidity.
Estimated duration 24 months
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research team propose to carry out a randomised crossover trial to assess the impact of AI on the quality of upper GI endoscopy
| Arm | Type | Receives |
|---|---|---|
| Endoscopists with AI feedback | Experimental | Device: Cerebro endoscopy quality control toolThis will be the group of endoscopists who will have AI feedback during the endoscopy |
| Endoscopists without AI feedback | Active comparator | Device: Cerebro endoscopy quality control toolThis will be the group of endoscopists without AI feedback during the endoscopy to assess their baseline site detection rate. Both arms will cross over to see if AI improves endoscopy quality and if its removal decreases quality. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects 18 years of age or above who are scheduled for outpatient diagnostic UGI endoscopy will be invited to part take in the study.
Key exclusion criteria (5 listed)
- Inpatient/ emergency OGD referrals
- Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion),
- Previous gastro-duodenal surgery
- Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)
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 |
|---|---|---|
| Cerebro endoscopy quality control toolThe AI provides feedback via a separate screen to the endoscopists to inform them which part of the upper GI tract have been adequately visualised. | Device | Endoscopists with AI feedback, Endoscopists without AI feedback |
Primary outcome
Number of sites successfully inspected during endoscopy (0-28)
Time frame: During time of endoscopy
Number of sites successfully inspected during endoscopy (0-28)
2 secondary outcomes
Overall procedure time
Time frame: During time of endoscopy
Individual site inspection time
Time frame: During time of endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No. All data will be anonymised and only aggregated data will be shared
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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.
Nigel Trudgill, MbChB contact
Nigel Trudgill, MbChB principal investigator
Sandwell General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Endoscopy, Digestive System, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 5 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amar Srinivasa, BMBS (07795084514, amarsrinivasa@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sites successfully inspected during endoscopy (0-28) (time frame: During time of endoscopy). 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 18 May 2023.