Trial Title:
Adenoma Detection Rate in Artificial Intelligence-assisted Colonoscopy
NCT ID:
NCT05740137
Condition:
Colorectal Cancer
Colorectal Adenoma
Colorectal Neoplasms
Conditions: Official terms:
Colorectal Neoplasms
Adenoma
Conditions: Keywords:
Artificial intelligence-assisted colonoscopy
Computer-aided polyp detection
Colorectal adenoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A quasi randomized controlled multicenter study
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
AI-assisted colonoscopy
Description:
The patients in the intervention group will receive an AI-assisted colonoscopy (AIC)
using the computer-aided polyp detection and characterization (CADe and CADx) GI Genius
(Medtronic).
Arm group label:
AI-assisted colonoscopy
Summary:
The goal of this quasi 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.
Detailed 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 quasi 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, quasi 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Referred for screening colonoscopy due to a positive faecal immunochemical test
(FIT) or for
- Diagnostic colonoscopy due to symptoms/signs or
- Post-polypectomy surveillance colonoscopy (only patients who had all detected polyps
removed in the previous colonoscopy)
Exclusion Criteria:
- Referral for removal of previous detected polyps
- Emergency colonoscopy
- Control colonoscopy due to inflammatory bowel disease (IBD)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Holbæk Hospital
Address:
City:
Holbæk
Zip:
4300
Country:
Denmark
Facility:
Name:
Zealand University Hospital
Address:
City:
Køge
Zip:
4600
Country:
Denmark
Facility:
Name:
Nykøbing Falster County Hospital
Address:
City:
Nykøbing Falster
Zip:
4800
Country:
Denmark
Facility:
Name:
Næstved Hospital
Address:
City:
Næstved
Zip:
4700
Country:
Denmark
Start date:
October 1, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Ismail Gögenur
Agency class:
Other
Collaborator:
Agency:
Nykøbing Falster County Hospital
Agency class:
Other
Collaborator:
Agency:
Naestved Hospital
Agency class:
Other
Collaborator:
Agency:
Holbaek Sygehus
Agency class:
Other
Collaborator:
Agency:
Slagelse Hospital
Agency class:
Other
Source:
Zealand University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740137
