Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With CADe (Discovery System) on Adenoma Detection Rate.
- Conditions
- Colorectal PolypColonoscopyAdenomaArtificial Intelligence
- Interventions
- Device: colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)
- Registration Number
- NCT05220345
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. 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, or lesions hidden behind folds in the colon. With this study we want to combine a device to flatten the folds in the colon combined with an artificial intelligence system to further improve the detection rate of lesions during colonoscopy.
- Detailed Description
Rationale: 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 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 population: 194 Adult patients (\>18 years) from 3 hospitals, scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy. Exclusion criteria: inflammatory bowel disease (IBD), 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 disorders or anticoagulation medication use, inability to provide informed consent.
Main study endpoints: The primary objective of the present study is to compare ADR between CADe assisted and a combined BTF/CADe assisted colonoscopy. Secondary objectives include advanced neoplasia rate (including advanced adenomas and/or CRC), polyp detection rate, size and histopathology, mean number of polyps per patient, procedure times, bowel cleaning levels, adverse events, inter-operator variability.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 194
- Adult patients (>18 years)
- Referred and scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy.
- Inflammatory bowel disease (IBD)
- 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
- inability to provide informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description colonoscopy with a combined BFT and CADe assisted approach colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe) This multicenter single-arm colonoscopy trial will compare colonoscopy assisted by both balloon-BFT visualizing and CADe to CADe-only assisted colonoscopy in diagnostic, screening (non-iFOBT based)), or surveillance colonoscopy. The latter group will be selected from the interventional arm from the Discovery II trial, using corresponding participating centers. All subjects in this trial will undergo the same treatment, i.e., combined balloon and CADe-assisted colonoscopy.
- Primary Outcome Measures
Name Time Method Adenoma Detection Rate (ADR) 30 days after procedure 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 Measures
Name Time Method Number of sessile serrated lesions 30 days after procedure Number of sessile serrated lesions
Polyp Detection Rate 30 days after procedure 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
Advanced adenoma detection rate (AADR). 30 days after procedure 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
Sessile detection Rate 30 days after procedure 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
Location of the lesion: cecum, ascending colon, transverse colon, descending colon, sigmoid, rectum; During procedure 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) During procedure Morphological characteristics of the lesion using the Paris classification (Ip, Is, IIa, IIb, IIc, III)
Bowel cleansing During procedure Using the Boston Bowel Prep Scale
Mean number of polyps detected per patient 30 days after procedure Mean number of polyps detected per patient
Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm During procedure Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, \>20 mm
Indication specific ADR, 30 days after procedure ADR specific for screening, diagnostic, or surveillance
Number of advanced adenomas (adenomas ≥ 10 mm and/or with a villous component and/or with HGD 30 days after procedure Number of advanced adenomas (adenomas ≥ 10 mm and/or with a villous component and/or with HGD
Histopathological characteristics of the lesion according to the Vienna classification 30 days after procedure Histopathological characteristics of the lesion according to the Vienna classification
Severe) adverse events (S)AEs up to 30 days post-procedure 30 days after 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.)
Gloucester Comfort Scale score and analgesia use During procedure Gloucester Comfort Scale score and analgesia use
Mean number of adenomas detected per patient 30 days after procedure Mean number of adenomas detected per patient
Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time) During procedure Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time)
Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines 30 days after procedure Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines
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 At end of study 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
Cecal intubation rate (CIR) During procedure Cecal intubation rate (CIR)
Trial Locations
- Locations (1)
Radboud university medical center Nijmegen
🇳🇱Nijmegen, Gelderland, Netherlands