Discovery: Pentax* Computer-aided Detection to Improve Adenoma Detection in a Real-time Setting - The Discovery I Study

Colorectal cancer (CRC) is the third most commonly diagnosed malignancy and the
fourth leading cause of death in the Western world. CRC usually develops from
focal changes within benign, precancerous polyps. Colonoscopy aims to early
detect and remove these precancerous polyps. Although colonoscopy is generally
considered to be the most accurate screening modality, a substantial number of
polyps are still missed. Two meta-analysis showed pooled miss rates for polyps
of any size of 22-26%, an adenoma miss rate (AMR) of 26% for diminutive polyps
(1-5mm) and an AMR of 27% for serrated polyps. Missed lesions may have the
possibility to develop into cancer and it is thought that at least 50% of all
interval carcinomas (iCRCs; defined as a cancer diagnosed between screening and
post-screening surveillance colonoscopies) arise from missed lesions during
colonoscopy. In recent years, a new solution to human error in detecting polyps
has been developed; computer-aided detection (CADe) systems. CADe systems use
deep learning to improve polyp and adenoma detection in a more consistent and
reliable way. In the past years, several CADe systems have been developed.
Albeit performance of these systems on offline videos and images seems
promising, evidence on the ability during real-time clinical practice is
lacking. Recently Pentax Medical has developed a CADe system, named
*Discovery*. Pre-clinical studies have shown a 90% and 75.2% sensitivity and
specificity, respectively, with an area under curve (AUC) of 91% for polyp
detection (unpublished data). We hypothesize that the use of the Pentax
Discovery system is feasible and safe.

The primary objective of this study is to evaluate the feasibility of the
Pentax CADe-system during colonoscopy procedures in terms of the polyp
detection rate (PDR). We hypothesize that the use of the Pentax CADe-system is
feasible and enables detection of colorectal polyps with a PDR of >=0.37,
corresponding to an ADR of >=0.25, in accordance to current guidelines.

Secondary objectives are the following:
- To assess which type and size of polyps are detected by the Pentax CADe-system
- To assess whether quality indicators for colonoscopy (e.g. ADR, withdrawal
time) are affected by the Pentax CADe-system
- To assess the safety of the Pentax CADe-system
- To evaluate the endoscopists* experience using the Pentax CADe-system
- To assess the diagnostic performance of the CADe System for detecting
colorectal adenoma (e.g. sensitivity, specificity, false positive rate)
- To assess the number of polyps that are primarily detected by the system

Prospective, multicenter cohort study including a total of 90 patients.

Patients will be enrolled for a period of 30 days, starting at the day of the
procedure and ending after 30 days of follow up. It is likely that the Pentax
CADe system will lead to the detection of more (adenomatous) polyps and thereby
resulting in more polypectomies, therefore participation in the study might
lead to a longer procedure time and more adverse events, especially the risk of
intraprocedural or delayed bleeding. Nonetheless, the risk of intraprocedural
or delayed bleeding is estimated to be low, i.e. 1.8% and <=0.1%, respectively.
Most bleedings can be treated during the same, or an additional colonoscopy,
procedure. The removal of additional polyps that are detected by the CADe
system might have a beneficial effect on the morbidity and mortality resulting
from colorectal carcinoma, depending on the type of polyp that is removed
during the procedure. The follow-up of the procedure (e.g. the number of
hospital visits) will take place according to local guidelines.