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Diagnostic Yield of Colon Capsule Endoscopy vs CT Colonography in a Screening Population
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The authors of this multicenter, prospective, randomized study compared the diagnostic yield of colon capsule endoscopy (CCE) with that of CT colonography (CTC) for colon cancer screening in an average-risk adult population. The proportion of individuals with any polyp ≥6 mm confirmed by colonoscopy was 31.6% with CCE versus 8.6% with CTC. The diagnostic yield of polyps ≥10 mm was 13.5% with CCE versus 6.3% with CTC. The sensitivity and specificity of CCE for polyps ≥6 mm were 79.2% and 96.3%, respectively, compared with 26.8% and 98.9%, respectively, with CTC. The sensitivity and specificity of CCE for polyps ≥10 mm were 85.7% and 98.2%, respectively, compared with 50% and 99.1%, respectively, with CTC.
- CCE is superior to CTC for detection of colon polyps ≥6 mm and is noninferior for detection of polyps ≥10 mm, but it should be noted that both are inferior to colonoscopy. A sequential approach with CCE followed by colonoscopy can be considered a screening option in those who decline colonoscopy as an initial screening modality or for patients in whom colonoscopy carries an increased risk.
abstract
This abstract is available on the publisher's site.
Access this abstract nowObjective
Colon capsule endoscopy (CCE) has shown promise for colorectal neoplasia detection compared with optical colonoscopy (OC), but has not been compared with other screening tests in average risk screening patients.
Design
Patients 50 to 75 years of age (African Americans, 45–75 years) were randomised to CCE or CT colonography (CTC) and subsequent blinded OC. The primary endpoint was diagnostic yield of polyps ≥6 mm with CCE or CTC. Secondary endpoints included accuracy for size and histology, examination completeness, number/proportion of subjects with polyps and adenomas ≥6 mm and ≥10 mm, subject satisfaction and safety.
Results
From 320 enrolled subjects, data from 286 (89.4%) were evaluable. The proportion of subjects with any polyp ≥6 mm confirmed by OC was 31.6% for CCE versus 8.6% for CTC (pPr non-inferiority and superiority=0.999). The diagnostic yield of polyps ≥10 mm was 13.5% with CCE versus 6.3% with CTC (pPr non-inferiority=0.9954). The sensitivity and specificity of CCE for polyps ≥6 mm was 79.2% and 96.3% while that of CTC was 26.8% and 98.9%. The sensitivity and specificity of CCE for polyps ≥10 mm was 85.7% and 98.2% compared with 50% and 99.1% for CTC. Both tests were well tolerated/safe.
Conclusion
CCE was superior to CTC for detection of polyps ≥6 mm and non-inferior for identification of polyps ≥10 mm. CCE should be considered comparable or superior to CTC as a colorectal neoplasia screening test, although neither test is as effective as OC.
Additional Info
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Gastroenterology
Despite the benefits of colorectal cancer (CRC) screening, screening rates are suboptimal. Higher rates of CRC screening are observed if multiple screening options are available. As such, the United States Preventive Services Task Force (USPSTF) endorses several screening modalities, including stool-based (FOBT, FIT, multitarget stool DNA), endoscopic (colonoscopy, sigmoidoscopy), and radiologic options (CT colonography). Although established as an accurate modality, colon capsule endoscopy (CCE) is not currently endorsed to screen average-risk patients.
Cash et al completed a randomized multicenter prospective parallel-group blinded trial comparing the utility of CCE with CT colonography (CTC) to detect polyps in average-risk patients. After randomization in a 1:1 ratio to complete a CCE or CTC, 286 patients underwent colonoscopy. The primary endpoint was the detection of polyps ≥6 mm between CCE and CTC and secondary endpoints included accuracy for ≥6 mm polyps and diagnostic yield and accuracy for ≥10 mm polyps. Compared with CTC, CCE detected significantly more ≥6 mm polyps and was noninferior in detecting ≥10 mm polyps. Sensitivity of polyps ≥6 mm was 79.2% for CCE and 26.8% for CTC. Sensitivity of polyps ≥10 mm was 85.7% for CCE and 50% for CTC. All screening modalities were well-tolerated, with low rates of adverse events. Participants preferred colonoscopy over CCE and CTC due to less time needed for the exam and ability to collect pathology.
This study clearly adds to the body of evidence supporting the utility of CCE to detect colon polyps and neoplasia. Colonoscopy will likely continue to be the gold standard given its high sensitivity, specificity, safety, and ability for therapeutic polypectomy. However, there are unique clinical scenarios in which colonoscopy is not ideal, feasible, or safe. Alternate, less-invasive CRC screening modalities are needed, and thus CCE should be seriously considered as another safe, feasible, and acceptable option for patients.