The primary objective of this study is to compare the effect on ADR of combining balloon-assisted and CADe assisted colonoscopy, compared to CADe assisted colonoscopy only.Secondary objectives are to compare the effect of adding balloon-assisted to…
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Source
Brief title
Condition
- Benign neoplasms gastrointestinal
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the ADR, calculated as the number of patients in
whom at least one adenoma is detected during the colonoscopy procedure, divided
by the total number of patients that underwent the colonoscopy procedure.
Secondary outcome
- AADR, calculated as the number of patients in whom at least one advanced
adenoma is detected during the colonoscopy procedure, divided by the total
number of patients that underwent the colonoscopy procedure
- PDR, calculated as the number of patients in whom at least one polyp is
detected during the colonoscopy procedure, divided by the total number of
patients that underwent the colonoscopy procedure
- TSDR, calculated as the number of patients in whom at least one SSL is
detected during the colonoscopy procedure, divided by the total number of
patients that underwent the colonoscopy procedure
- Indication specific ADR, i.e., ADR specific for screening, diagnostic, or
surveillance
- Mean number of adenomas detected per patient
- Mean number of polyps detected per patient
- Number of sessile serrated lesions
- Number of advanced adenomas (adenomas >= 10 mm and/or with a villous component
and/or with HGD
- Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm
- Location of the lesion: cecum, ascending colon, transverse colon, descending
colon, sigmoid, rectum;
- Morphological characteristics of the lesion using the Paris classification
(Ip, Is, IIa, IIb, IIc, III)
- Histopathological characteristics of the lesion according to the Vienna
classification
- ADR of the first 20% of patients that have undergone colonoscopy by each
endoscopist will be compared with the final 20% of patients in each arm to
identify any changes in ADR throughout the trial
- Bowel cleansing using the BBPS
- Cecal intubation rate (CIR)
- Procedure times with both techniques (i.e., total procedure time, mean
polypectomy time and withdrawal time)
- (Severe) adverse events (S)AEs up to 30 days post-procedure
- SAEs will be subcategorized into colonoscopy related, cardiac (cardiac
ischemia, heart failure, arrhythmia, other) pulmonary (exacerbation COPD,
infectious, other), neurological (stroke, cerebrovascular accident, bleeding,
other), and other (surgical interventions etc.)
- GCS score and analgesia use
- Post-colonoscopy surveillance intervals when applying European and US
surveillance guidelines
Background summary
Colonoscopy is the gold standard for CRC screening. The adenoma detection rate
(ADR) is the most important quality parameter for colonoscopy, because of its
inverse association with the risk of interval CRC. Yet, the adenoma miss rate
(AMR) in conventional colonoscopy is reported in meta-analyses to vary between
22-26%. The diagnostic accuracy of colonoscopy highly depends on the quality of
inspection of the colonic mucosa during the procedure. To increase the adenoma
detection rate (ADR), new polyp/adenoma detection systems based on artificial
intelligence (AI) have been developed, i.e., computer assisted detection
(CADe). However, these systems still depend on the ability of the endoscopist
to adequately visualize the complete colonic mucosa, especially to detect
smaller and more subtle lesions. Therefore, we hypothesize that ADR can further
be improved by combining a CADe system, the Discovery system, with a behind the
fold (BTF) visualization technique, the G-Eye.
Study objective
The primary objective of this study is to compare the effect on ADR of
combining balloon-assisted and CADe assisted colonoscopy, compared to CADe
assisted colonoscopy only.
Secondary objectives are to compare the effect of adding balloon-assisted to a
CADe-assisted colonoscopy on:
- Advanced adenoma detection rate (AADR). Adenomas are classified as advanced
with a size >=10mm and/or a (tubulo)villous histology and/or high-grade
dysplasia (HGD);
- Polyp detection rate (PDR);
- Sessile serrated lesion (SSL) detection rate (SDR);
- Mean number of polyps per patient;
- Size, morphology, and histopathology of lesions found.;
- Procedure time, including total procedure time, mean polypectomy time,
withdrawal time;
- Bowel cleaning using the Boston Bowel Preparation Scale (BBPS);
- Cecal intubation rate;
- Patient comfort, using the Gloucester Comfort Scale (GCS) and sedation and
analgesia use;
- Safety, in terms of (severe) adverse events up to 30 days post-procedure;
- Interoperator variability and learning curve;
- Post-colonoscopy surveillance intervals using European (ESGE) and US (ASGE)
surveillance guidelines;
Study design
International multicenter prospective interventional cohort, compared with a
cohort from the Discovery II study (NL73127.091.20, trial code NL9135). All
subjects will be undergoing colonoscopy with a combined BFT and CADe assisted
approach. Outcomes will be corrected for confounders using regression modeling.
Study burden and risks
Eligible patients who are scheduled for surveillance colonoscopy will undergo
one BFT and CADe assisted colonoscopy. There will be no burden for participants
regarding the colonoscopy procedure. Colonoscopy is a commonly performed
procedure, and the overall serious adverse event rate is low with an estimated
risk 2.8 per 1000 colonoscopies. The risk of experiencing a (serious) adverse
event with G-Eye and Discovery guided colonoscopy is believed to be equivalent
to conventional colonoscopy. The benefit for patients is a higher likelihood of
lesion detection during colonoscopy.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Adult patients (>18 years)
Referred and scheduled for diagnostic, screening (non-iFOBT based), or
surveillance colonoscopy.
Exclusion criteria
- Known polyp or tumor upon referral
- Therapeutic procedure (e.g., endoscopic mucosal resection)
- Prior surgical resection of any portion of the colon
- American Society of Anesthesiologists score of >=3
- Inadequately corrected anticoagulation disorder or anticoagulation medication
use
- Inflammatory bowel disease (IBD)
- inability to provide informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80004.091.21 |