Launched in 2020 and nested in the Danish Colorectal Cancer Screening Program, aims to evaluate the effectiveness of colon capsule endoscopy (CCE) as an intermediate screening method between the faecal immunochemical test (FIT) and colonoscopy in colorectal cancer (CRC) screening.
Conducted in the Region of Southern Denmark, the study randomly allocated 368 452 eligible citizens into two groups: an intervention group and a control group. Participants in the intervention group were informed that if they tested positive on the FIT, they could opt for CCE instead of proceeding directly to a colonoscopy. The control group followed the standard screening procedures, where a positive FIT result led directly to a colonoscopy.
In the intervention group, CCE findings determined subsequent actions. Suspected cancers, more than two polyps any size, or a single polyp larger than 9 mm detected during CCE prompted an invitation for a colonoscopy. Participants with suspected low-risk polyps were scheduled to re-enter the biennial screening program, while those with no findings were excluded from screening for eight years in accordance with regular screening protocols.
The primary objectives of the study were to assess the clinical performance of CCE, gauge its acceptability among the population, and analyze the economic implications of incorporating CCE into the CRC screening process. All participants provided consent prior to capsule ingestion, and data collection adhered to current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish Data Protection Agency (ref. 19/29858) were obtained.
By integrating CCE as a filter test between FIT and colonoscopy, the study explored a potential pathway to enhance CRC screening efficiency, improve patient compliance, and optimize resource utilization within the healthcare system.
