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DOI: 10.1055/s-0038-1637306
DIAGNOSTIC PERFORMANCE OF COLON CAPSULE ENDOSCOPY (CCE2). A PROSPECTIVE MULTICENTER STUDY IN A SCREENING SETTING
Publication History
Publication Date:
27 March 2018 (online)
Aims:
To assess CCE-2 diagnostic accuracy in screenees with a positive faecal immunochemical test (FIT) in population based programmes for colorectal cancer (CRC) screening.
Methods:
subjects aged 50 to 69, with a positive FIT, examined in 4 population programmes in Italy and Spain were enrolled. Same test (Eiken co.) and same positivity cut-off (20µgr. Hb/gr. faeces) were adopted. Screenees were asked to perform CCE-2, followed by colonoscopy (TC). TC was performed the same day if CCE-2 was excreted before 2 p.m.. TC was scheduled for the following morning after an additional bowel preparation if CCE-2 was excreted after 2pm. Bowel preparation for CCE-2 included a splitted PEG-based regimen and NaP and Gastographin as boosters. CCE-2 video was read by an endoscopist blinded to the results of TC. The main outcomes were CCE-2 sensitivity and specificity for advanced neoplasia, when using different size thresholds for TC referral (i.e. > 5 or > 9 mm polyp).
Results:
222 subjects were enrolled and 203 completed both CCE-2 and TC. Quality of bowel preparation for CCE-2 was adequate in 88.5% of cases. A complete examination was achieved in 96.6% of cases with TC and in 88.2% with CCE-2. TC detected an AN in 32.4% of screenees with complete CCE-2 exam. CCE-2 sensitivity for AN was 75.9% and 89.7% when using the higher (≥1 polyp > 9 mm; TC referral rate; 36.3%) or the lower (≥1 polyp > 5 mm; TC referral rate 52.5%) thresholds; AN specificity were 82.6% and 65.3%, respectively.
Conclusions:
Our results confirm in a high-prevalence population the findings from previous reports showing a high sensitivity of CCE-2 for significant colorectal lesions. The lower CCE-2 specificity as compared to previous reports is likely related to the choice of AN as the main outcome, as opposed to large polyps (any histology).