The Impact of Artificial Intelligence (AI) on the Quality of Upper Gastrointestinal (GI) Endoscopy
NCT ID: NCT05845463
Last Updated: 2023-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
300 participants
INTERVENTIONAL
2023-06-01
2025-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
1. Ensures inspection completeness prompting the endoscopist on which areas have been missed.
2. Calculates the time spent at each landmark ensuring at least a 7-minute examination time.
3. Provides automatic photodocumentation which allows for better reporting
4. 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Application of Artificial Intelligence for Early Diagnosis of Gastric Cancer During Optical Enhancement Magnifying Endoscopy
NCT04563416
Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy
NCT04937647
Gastrointestinal Endoscopy Artificial Intelligence Cloud Platform in Gastrointestinal Endoscopy Screening
NCT05435872
Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality
NCT05851716
Single-center, Randomized, Superiority Pivotal Clinical Study to Evaluate the Efficacy of Artificial Intelligence-based Upper Gastrointestinal Endoscopy Image
NCT06969794
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Endoscopists with AI feedback
This will be the group of endoscopists who will have AI feedback during the endoscopy
Cerebro endoscopy quality control tool
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.
Endoscopists without AI feedback
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.
Cerebro endoscopy quality control tool
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cerebro endoscopy quality control tool
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sandwell & West Birmingham Hospitals NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nigel Trudgill
Consultant Gastroenterologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nigel Trudgill, MbChB
Role: PRINCIPAL_INVESTIGATOR
Sandwell General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sandwell General Hospital
Birmingham, West Midlands, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V0.1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.