The comparison of the efficiency of colon capsule endoscopy and optical colonoscopy in patients with positive immunochemical fecal occult blood test: multicenter, prospective study
MUDr. Michal Voška1; MUDr. Tomáš Grega1; MUDr. Gabriela Vojtěchová1; Mgr. Ondřej Ngo2; RNDr. Ondřej Májek, Ph.D.2; Mgr. Barbora Bučková2; doc. MUDr. Ilja Tachecí, Ph.D.3; MUDr. Marek Beneš4; prof. MUDr. Jan Bureš, CSc.3; prof. MUDr. Julius Špičák, CSc.4; prof. MUDr. Miroslav Zavoral, Ph.D.1; doc. MUDr. Štěpán Suchánek, Ph.D.1
1 Interní klinika, 1. LF UK a Ústřední vojenská nemocnice - Vojenská fakultní nemocnice, Praha
2 Institut biostatistiky a analýz, LF MU, Brno
3 II. interní gastroenteroíogická klinika, LF UK a FN Hradec Králové
4 Klinika hepatogastroenteroíogie, Institut klinické a experimentální medicíny, Praha
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).
Main aim of the study was negative predictive value (NPV) of the second generation of colon capsule endoscopy (CCE2) for large polyps (≥ 10 mm). The secondary aims were accuracy of detection of all polyps (polyps ≥ 6 mm and ≥ 10 mm) and cancers, number of complications and target population acceptance of both methods (CCE2 and OC).
Material and methods: In this multicenter (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 with cut-off level 75 ng/ml. Colonoscopy was performed within 10 hours after capsule ingestion. CCE2 videos were viewed independently by a nurse and a physician, both blinded to the results of OC. Complications were assessed as serious (bleeding, perforation) or mild to moderate. The methods of acceptance were evaluated based on the questionnaire completed after both procedures (CCE2 and OC) were finished. The interim analysis of results is presented.
Results: From April 2016, 248 individuals have been enrolled; data from 178 persons has been analyzed. During optical colonoscopy, polyps were diagnosed in 144 persons (81%), polyps ≥ 6 mm and ≥ 10 mm in 90 (51%) and 47 (26%) persons, respectively. The sensitivity of CCE2 for polyps ≥ 6 mm and ≥ 10 mm was 82% (95% confidence interval [CI]: 73-89%) and 79% (95% CI: 64-89%), respectively. The specificity 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 of 90 (83%) and 37 polyps ≥ 10 mm of 47 (79%) found on OC. A total of 119 patients (66%) preferred CCE2 as the primary screening method. 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. This method might be considered as an adequate tool for colorectal cancer screening.
colorectal cancer, colon capsule endoscopy, optical colonoscopy, fecal immunochemical tests, accuracy, sensitivity, specificity
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