Comparison of efficiencies of colon capsule endoscopy and optical colonoscopy in patients with a positive immunochemical fecal occult blood test – a multicentre, prospective study
Michal Voška1, Tomáš Grega2, Gabriela Vojtěchová2, Ondřej Ngo3,4, Ondřej Májek5, Barbora Bučková4, Ilja Tachecí6, Marek Beneš7, Jan Bureš6, Julius Špičák7, Miroslav Zavoral1, Štěpán Suchánek1
1 Interní klinika 1. LF UK a ÚVN – VFN Praha
2 Interní klinika 1. LF UK a ÚVN – VFN v Praze
3 Ústav zdravotnických informací a statistiky ČR, Praha
4 Institut biostatistiky a analýz, LF MU, Brno
5 Institut biostatistiky a analýz LF MU, Brno
6 II. interní klinika – gastroenterologie, LF UK a FN Hradec Králové
7 Klinika hepatogastroenterologie, Transplantcentrum, IKEM, Praha
Background: Colon capsule endoscopy (CCE) has the potential to become a so-called filter test in individuals with a positive faecal immunochemical test (FIT). The main objective of the study is to determine the negative predictive value of the second generation colonial capsule (CCE2) for polyps ≥ 10 mm. Material and methods: Since 2016, asymptomatic individuals of screening age with a positive FIT, without an increased risk of colorectal neoplasia, who were examined by CCE2 (independently described by a doctor and a trained nurse) and then immediately by standard optical colonoscopy (OC) have been included in a prospective study in three Czech endoscopic workplaces. The main monitored parameter was the negative predictive value of CCE2 for large polyps (≥ 10 mm), followed by the detection of polyps ≥ 6 mm, ≥ 10 mm, adenomas ≥ 10 mm and carcinomas, intestinal preparation level, examination tolerance, and CCE complications. Results: So far, 248 individuals have been enrolled, and the data from 178 individuals with full results have been analyzed. OC polyps were diagnosed in 144 persons (81%), of whom 90 (51%) and 47 (26%) had polyps ≥ 6 mm and ≥ 10 mm, resp. The sensitivities of CCE2 for polyps ≥ 6 mm and ≥ 10 mm were 82% (95% confidence interval [CI]: 73–89%) and 79% (95% CI: 64–89%), respectively. The specificities for polyps ≥ 6 mm and ≥ 10 mm reached 85% (95% CI: 76–92%) and 92% (95% CI: 86–96%), respectively. The negative predictive value of CCE2 for polyps ≥ 10 mm was 92% (95% CI: 86–96%). Nurses identified 73 polyps ≥ 6 mm in 90 individuals (83%) and 37 polyps ≥ 10 mm in 47 (79%) by OC. A total of 119 patients (66%) preferred CCE2 as the primary screening method. Conclusion: CCE2 achieves a high negative predictive value for large polyps. It is a well-accepted method with the potential of becoming a filter test in individuals with a positive FIT.
Keywordsadenoma, faecal immunochemical tests, colonic capsule, colorectal cancer, optic colonoscopy
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