Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05740137 |
| Other study ID # |
REG-092-2022 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
September 30, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Zealand University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this cluster randomized multicenter controlled clinical trial (RCT) is to
investigate whether a combined real time computer-aided polyp detection (CADe) and
computer-aided polyp characterization (CADx) system (GI Genius, Medtronic) can increase the
adenoma detection rate (ADR) and reduce the performance variability among endoscopists.
Participants will be randomized (1:1) to either receive an AI-assisted colonoscopy (AIC) or a
conventional colonoscopy (CC).
If there is a comparison group: Researchers will compare the AIC-group and the CC-group to
see if AIC can increase the ADR significantly.
Description:
Colorectal cancer (CRC) is the third most common cancer, and the second most common cause of
cancer-related death worldwide. CRC screening is used for detection and removal of
precancerous lesions before they develop into cancer. Colonoscopy is regarded being superior
to other screening tests, and is therefore used as the golden standard.
Screening colonoscopy is associated with a reduced risk of CRC-related death. Since it is not
possible for an endoscopist to determine the histopathology of the polyp with certainty
during a colonoscopy, detected pre-malignant lesions should be removed and sent for
histological examination. Multiple studies have shown that there is a strong association
between findings at the baseline screening colonoscopy and rate of serious lesions at the
follow up colonoscopy. Risk factors for adenoma, advanced adenoma and cancer at follow-up
colonoscopy are multiplicity, size, villousness, and high degree dysplasia of the adenomas at
the baseline screening colonoscopy.
The adenoma detection rate (ADR) is the percentage of examinations performed by one
endoscopist, in which one or more adenomas are found. This is widely accepted as the main
quality indicator for each endoscopist and colonoscopy. There is strong evidence that the ADR
is inversely correlated to the incidence of interval CRC. With each 1,0% increase in the ADR
there is a 3,0% decrease in the risk of developing CRC. Unfortunately, adenomas and advanced
adenomas are frequently missed, and the ADR varies widely among different endoscopists. Also,
the quality changes throughout the day. Both the withdrawal time and the ADR decreases by the
end of the day, approximately by 20% and 7% respectively. Small improvements in the
colonoscopy quality may have great importance for the outcome when screening for CRC.
Artificial intelligence (AI) can reduce the performance variability by working as a pair of
additional virtual eyes, compensating for perceptual errors due to fatigue, distraction and
inaccurate human vision. Within the last few years there have been published several
randomized controlled trials (RCT) investigating the efficacy of real time computer-aided
detection. Among these, all of the RCT´s which have ADR as the primary outcome, have shown
that the use of AI contributes to a significantly higher ADR, compared colonoscopies without
assistance of an AI system.
Repici et al. have shown that experience of the endoscopist only plays a minor role as a
determining factor. Correspondingly, results from a previous study by Liu et al. indicates
that CADe systems are not only useful for endoscopists with a low detection rate, but can
also increase the ADR for more experienced endoscopists. Kamba et. al reports a significant
lower adenoma miss rate (AMR) for CADe-assisted colonoscopy, compared to a conventional
colonoscopy. This is independent on the endoscopist´s level of expertise. Other studies
conclude that AI probably will benefit the less experienced endoscopists more. However, there
are only a limited number of studies investigating the impact of AI when used by less
experienced endoscopists.
According to a recent RCT from Wallace et al. the use of AI can reduce the AMR by
approximately 50%, but primarily due to increased detection of small (<10 mm) flat neoplasia.
This difference is slightly higher than in a previous study, in which the relative reduction
was approximately 35%. However, in this study there were no significant difference in missed
diminutive polyps (<10 mm).
In a systematic review the overall withdrawal time was shown to be higher with AI-assisted
colonoscopy (AIC), compared to conventional colonoscopy (CC), but the ADR and PDR was also
higher. Naturally, there have been concerns about prolonged colonoscopy time, and increased
workload if implementing the AI system, since the increased detection of small polyps may
lead to unnecessary polypectomy. However, two recent RCT´s report that the unnecessary
resection of non-neoplastic polyps did not increase by using the CADe system.
The results so far are promising, suggesting that AIC is superior to CC when it comes to
polyp and adenoma detection. Routine use of computer-aided polyp detection (CADe) systems
could further reduce the incidence of interval CRC, but more clinical data from large
multicenter randomized trials are required to understand the actual impact of AI in the daily
clinical setting.
We have designed a quality assurance multicenter RCT to investigate the effect of real time
AI-assistance (GI Genius, Medtronic) on adenoma detection rate (ADR) in both experienced and
less experienced endoscopists. We want to investigate whether the CADe system can reduce the
performance variability and increase the ADR significantly.
The overall aim of this research is to investigate if AI-assistance in colonoscopy can
increase the ADR.
This prospective, multicenter, randomized controlled trial (RCT) will take place at four
endoscopy units in Region Zealand, Denmark. These units are located at Zealand University
Hospital (Køge), Nykøbing Falster Hospital, Holbæk Hospital and Næstved Hospital. All units
except Næstved Hospital are participating in the national CRC-screening programme.
We will screen all patients scheduled for screening, diagnostic, and surveillance
colonoscopy. The eligible patients will receive a colonoscopy from an expert or a non-expert
endoscopist based on the normal distribution of endoscopists at the endoscopic units.
