Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05845463 |
| Other study ID # |
V0.1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
June 1, 2025 |
Study information
| Verified date |
May 2023 |
| Source |
Sandwell & West Birmingham Hospitals NHS Trust |
| Contact |
Amar Srinivasa, BMBS |
| Phone |
07795084514 |
| Email |
amarsrinivasa[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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). 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)
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.
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
