Applicability of colon capsule endoscopy in FIT-positive individuals unable or unwilling to undergo colonoscopy within a colorectal cancer screening programme: a prospective multicentre study

Background: 

Colorectal cancer (CRC) screening programmes commonly use the Faecal immunochemical test (FIT) followed by colonoscopy. When colonoscopy is not feasible, computed tomography colonography (CTC) serves as an alternative. However, CTC has limitations, such as lower sensitivity for smaller polyps and radiation exposure. Colon capsule endoscopy (CCE) is a non-invasive alternative that may improve polyp detection in FIT-positive individuals. 

Objectives: 

To evaluate the feasibility of CCE in FIT-positive participants from the Dutch CRC screening programme who are unable or unwilling to undergo colonoscopy. Design: Prospective multicentre, interventional study. Methods: FIT-positive participants ingested the PillCam^® Colon 2 capsule. Colonoscopy was recommended if polyp(s) ⩾6 or suspected malignancy were detected. The primary outcome was the per-patient polyp detection rate (PDR) for polyps ⩾6 mm. 

Results: 

Of 169 FIT-positive participants unable to undergo colonoscopy, 54.4% were ineligible for CCE due to contraindications. CCE was performed in 13 participants, with a completion rate of 69.2% and adequate bowel preparation in 38.5. A total of 54 polyps were detected, 46.3% of which were ⩾6 mm. The per-patient detection rate for polyps ⩾6 mm was 76.9%. In 84.6% of cases, follow-up colonoscopy was advised. CCE findings matched colonoscopy in 66.7% of cases; in the remaining 33.3%, polyps were found to be < 6 mm during colonoscopy. One participant was diagnosed with a pT4bN0M0 adenocarcinoma after CCE revealed a tumorous obstruction.

Conclusion: 

Despite a high per-patient PDR, this study indicates that CCE is less suitable for FIT-positive individuals unable or unwilling to undergo colonoscopy due to high comorbidity and frequent contraindications. Inadequate bowel preparation, likely due to reduced gastrointestinal motility, further limited feasibility. Given the elevated risk of advanced neoplasia in this population, many still required follow-up colonoscopy. Therefore, CCE may be better suited for lower-risk populations with fewer procedural limitations. Trial registration: Overview of Medical Research in the Netherlands, NL-OMON55511.