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Background Fecal immunochemical tests (FIT) have been used as an initial test in CRC screening programs. However, majority of patients don`t have advanced neoplasia on colonoscopy. Colon capsule endoscopy (CCE) has the potential to reduce the need for optical colonoscopy (OC). Material and methods: In this multicentre (three gastroenterology units) feasibility study, second generation of colon capsule endoscopy (CCE2) has been prospectively compared with OC in persons with positive semi-quantitative FIT. CCE2 videos were viewed independently by a nurse and a physician, both blinded to the results of OC. Main aim of the study was negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm). The secondary aims were: accuracy of detection of all polyps and cancers and number of complications. Results: From April 2016, 111 individuals have been enrolled; data from 54 persons has been analyzed. During optical colonoscopy, polyps were diagnosed in 37 persons (69%), polyps ≥ 6 mm and ≥ 10 mm in 22 (41%) and 12 (22%) persons, respectively. The sensitivity of CCE2 for polyps ≥ 6 mm and ≥ 10 mm was 82% (95% confidence interval [CI]: 60-95%) and 75% (95% CI: 43-95%), respectively. The specificity for polyps ≥ 6 mm and ≥ 10 mm reached 88% (95% CI: 71-96%) and 93% (95% CI: 81-99%), respectively. Two cancers were diagnosed at both CCE2 and OC. The negative predictive value of CCE2 for polyps ≥ 10 mm was 93% (95% CI: 81-99%). Nurses identified 17 polyps ≥ 6 mm of 22 (77%) and 10 polyps ≥ 10 mm of 12 (83%) found on OC. No patient had serious adverse event that was related to both methods. Conclusion: Second generation of colon capsule has appeared to have a high negative predictive value for the detection of clinically relevant colorectal neoplasia in screening population.

Backround. Capsule colonoscopy might present an alternative to colonoscopy for colorectal neoplasia screening. Aim. To assess the accuracy of second-generation capsule colonoscopy (CCE2) for colorectal neoplasia detection compared with conventional colonoscopy (CC). Methods. From 2011–2015, we performed a multicenter, prospective, cross-over study evaluating the use of CCE2 as a possible colorectal cancer (CRC) screening test based on the assessment of the method’s characteristics (accuracy) and safety and patient acceptance of the routine. Enrolled participants fulfilled the CRC screening population criteria if they were asymptomatic, were older than 50, and had no personal or familial history of colorectal neoplasia. The primary outcome was accuracy for the detection of polyps≥6 mm. Secondary outcomes were accuracy for all polyps, polyps≥10 mm, adenomas≥10 mm, and cancers, the quality of bowel cleansing, safety, and CCE2 acceptability by the screening population. Results. A total of 236 individuals were examined; 11 patients (5%) were excluded. Therefore, 225 subjects (95%) were considered in the intention-to-screen (ITS) group. A total of 201 patients (89%) completed both examinations successfully (per protocol group). In the ITS group, polyps were diagnosed during CC in 114 subjects (51%); polyps≥6 mm, polyps≥10 mm, and adenomas≥10 mm were diagnosed in 34 (15%), 16 (7%), and 11 (5%) patients, respectively. The sensitivity of CCE2 for polyps≥6 mm, polyps≥10 mm, and adenomas≥10 mm was 79% (95% confidence interval (CI): 62–91%), 88% (95% CI: 62–98%), and 100% (95% CI: 72–100%), respectively. Conclusion. Second-generation capsule colonoscopy is a safe, noninvasive, and sensitive method for colorectal neoplasia detection although CC remains the preferred method for considerable proportion of subjects. CCE2 may therefore be accepted as the primary screening test for colorectal cancer screening.

Adenoma detection rate (ADR) is the primary quality indicator for colonoscopy; however, it is difficult to obtain in terms of time and personnel. Polyp detection rate (PDR) is an alternative indicator easily evaluated from administrative data. The main aim of the study was to assess whether PDR and ADR are correlated and to determine the conversion factor to predict ADR from PDR in preventive (screening and FOBT+) colonoscopies.