BACKGROUND AND AIMS: Colon capsule endoscopy (CCE) has been recognized as an alternative for colorectal cancer (CRC) screening in average-risk people. Our aim was to prospectively assess the accuracy of CCE as a screening tool in first-degree relatives (FDRs) of people with CRC by using optical colonoscopy (OC) with segmental unblinding as the reference standard.
METHODS: Consecutive patients admitted with a CRC diagnosis (index cases) were prospectively evaluated and invited to contact their FDRs. Available FDRs were invited to undergo CCE and OC on the following day, with segmental unblinding of CCE results. Sensitivity, specificity, and predictive values/negative predictive values (PPV/NPV) of CCE were assessed for detecting patients with any polyp ≥6 mm and ≥10 mm.
RESULTS: A total of 177 FDRs (median age 57.0 years, 54.8% female) identified from 211 index cases were included. Both CCE and OC were completed in all the included FDRs. Overall, CCE identified 51 of 56 FDRs with polyps ≥6 mm (sensitivity 91%; 95% CI, 81-96) and correctly classified as negative 107 of 121 participants without lesions ≥6 mm (specificity 88%; 95% CI, 81-93). Per-patient positive and negative predictive values for ≥6 mm lesions were 78% (95% CI, 67-87) and 95% (95% CI, 90-98), respectively. CCE detected 24 of 27 patients with polyps ≥10 mm and correctly classified as negative 142 of 150 patients, corresponding to 89% sensitivity and 95% specificity. Post-CCE referral rates to colonoscopy were 37% and 18%, respectively.
CONCLUSIONS: CCE is an accurate method to screen FDRs of patients with CRC and could be offered as an alternative to those who decline or are unfit for colonoscopy screening. (Clinical trial registration number: NCT01184781.).
- Capsule Endoscopy/methods
- Colorectal Neoplasms/diagnosis
- Early Detection of Cancer/methods
- Medical History Taking
- Middle Aged
- Predictive Value of Tests
- Prospective Studies
- Sensitivity and Specificity