Polyp of Colon
Conditions
Keywords
Colonic polyp, Artificial intelligence, Second observer
Brief summary
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
Detailed description
This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR \> 20% and \< 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.
Interventions
DIAGNOSTIC_TESTArtificial intelligence for polyp detection
Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer
Sponsors
Nuovo Regina Margherita Hospital, Rome, Italy
Universitäts Medizin, Mainz, Germany
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \> 18 years * Diagnostic or screening colonoscopy * Therapeutic colonoscopy
Exclusion criteria
* Inability to give informed consent by the patient or legal representative * \< 18 years old * Any contraindication for colonoscopy or biopsies of the colon * Uncontrolled coagulopathy * Confirmed diagnosis of inflammatory bowel disease * Short bowel or ileostomy * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard | 4 months | Determination of the diagnostic accuracy of the novel AI system as second observer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist's polyp miss rate as number of extra AI detections | 4 months | Determination of the AI system's precision and extra value as second observer |
Countries
Belgium
Outcome results
None listed