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 Voška Orcid.org 1, Tomáš Grega Orcid.org 2, Gabriela Vojtěchová2, Ondřej Ngo3,4, Ondřej Májek Orcid.org 5, Barbora Bučková4, Ilja Tachecí Orcid.org 6, Marek Beneš Orcid.org 7, Jan Bureš Orcid.org 6, Julius Špičák Orcid.org 7, Miroslav Zavoral Orcid.org 1, Štěpán Suchánek Orcid.org 1
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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