Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. "Back-to-back" colonoscopies have indicated significant miss rates of 27% for small adenomas (< 5 mm) and 6% for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as high as 12%. The clinical importance of missed lesions should be emphasized because these lesions may ultimately progress to CRC.
Limitations in human visual perception and other human biases such as fatigue, distraction, level of alertness during examination increases such recognition errors and way of mitigating them may be the key to improve polyp detection and further reduction in mortality from CRC. In the past years, a number of CAD systems for detection of polyps from endoscopy images have been described. However, the benefits of traditional CAD technologies in colonoscopy appear to be contradictory, therefore they should be improved to be ultimately considered useful. Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have shown potential to assist polyp detection during colonoscopy.
Average experienced endoscopists (each having performed <2000 screening colonoscopies) will perform the endoscopic procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI | Artificial intelligence colonoscopy |
| |
| Control | White light colonoscopy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI | Device | Artificial intelligence colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of AI-aided colonoscopy in terms of ADR | The proportion of participants with at least one adenoma (per-patient analysis). | 5 Months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Based on the observed prevalence of adenomas (35%) among patients undergoing colonoscopies at our center within the last 12 months, a sample size of 322 subjects per arm could allow for a 90% power to show the non-inferiority (primary end-point) of the AI-aided arm by excluding that the one-side 95% CI will exclude a difference of 10% in favour of the standard group. Such sample size will also have a 80% power to detect as statistical significant (α=0.05; two-sided test) a 10% absolute increase in the detection rate of adenomas in the AI-aided arm (secondary end-point).
Performing a sub-stratification according to operator experience, we will planning to enroll the 322 subjects per arm performed by experts and 322 subjects per arm performed by average operator.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Repici, MD | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Poliambulanza | Brescia | Italia | Italy | |||
| Endoscopy Unit, Humanitas Research Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Rozzano |
| Milano |
| 20089 |
| Italy |
| Ospedale Valduce | Como | 22100 | Italy |
| Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital | Rome | 00153 | Italy |
| Ente Ospedaliero Cantonale, Ospedale Italiano | Lugano | 6900 | Switzerland |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |