Background: Colon capsule endoscopy (CCE) is a technology that might contribute to colorectal cancer (CRC) screening programs as a filter test between fecal immunological test and standard colonoscopies (SC). The aim was to systematically review the literature for studies investigating the diagnostic yield of 2nd generation CCE compared to SC. Methods: A systematic literature search was performed in PubMed, Embase and Web of Science. Study characteristics including quality of bowel preparation and completeness of CCE transits were extracted. Per-patient sensitivity and specificity were extracted for polyps (any size; ≥ 10mm, ≥6 mm) and lesion characteristics. Meta-analyses of diagnostic yield were performed. Results: The literature search revealed 1077 unique papers and 12 studies were included. These included 2199 in total of which 1898 patients were available for analyses. The rate of patients with adequate quality of the bowel preparation varied from 40% to 100%. The rates of complete CCE transits varied from 57% to 100%. Our meta-analyses demonstrated that mean [95% confidence interval] sensitivity, specificity and diagnostic odds ratio was 0.85 [0.73;0.92], 0.85 [0.70;0.93] and 30.5 [16.2;57.2], respectively for polyps of any size, 0.87 [0.82;0.90], 0.95 [0.92;0.97] and 136.0 [70.6;262.1], respectively for polyps ≥ 10mm and 0.87 [0.83;0.90], 0.88 [0.75;0.95] and 51.1 [19.8;131.8], respectively for polyps ≥ 6mm. No serious adverse events were reported for CCE. Conclusion: In conclusion, CCE has a high sensitivity and specificity for per-patient polyps compared to SC. However, the relatively high rate of incomplete investigations limits the application of CCE in a CRC-screening setting.
Purpose The aim of this study was to investigate the effect of response time from the Fecal Immunochemical Test (FIT) based screening invitation to the conclusive screening Optical Colonoscopy (OC) on the risk of detecting colorectal cancer (CRC), advanced stage disease and precursor lesions. Patients and methods We used a cross-sectional study design and included all 62,554 screening participants registered in the Danish Colorectal Cancer Screening Database who tested FIT-positive between March 2014 and December 2016. The main exposure was response time, measured as the time from initial invitation to the conclusive OC. Our main outcomes were the probability of being diagnosed with CRC, advanced stage disease or precursor lesions. Results Of the 62,554 FIT-positive participants, 53,171 (85%) received an OC and were eligible for analysis (median age 63.7 years, 56% men). In this group, 3,639 cancers were registered, 2,890 of which were registered with a defined stage of disease (79%), and 1,042 (36%) of these were advanced stage (UICC III & IV). In addition, 17,732 high-risk and 10,605 low-risk adenomas were identified. Compared to participants receiving the conclusive examination within 30 days, those receiving the examination more than 90 days after initial invitation were 3.49 times more likely to be diagnosed with any CRC (OR 3.49 [95% CI, 3.13–3.89]) and 2.10 times more likely to have advanced stage disease (OR 2.10 [95% CI, 1.73–2.56]). Those waiting for the longest were also more likely to have one or more high-risk adenomas (OR 1.59 [95% CI, 1.50–1.68]). Conclusion Increased screening response time was associated with a higher probability of detecting high-risk adenomas, any stage CRC and advanced stage cancer. More research is needed to explain what causes these associations.
IntroductionThe use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial.Methods and analysisWe will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas <10 mm in size, 1 adenoma >10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures.Ethics and disseminationAll participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858).Trial registration detailsThe study has been registered with ClinicalTrials.gov under: NCT04049357.
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