Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015

Background and study aims The Danish CareForColon2015 trial, launched in 2020 as part of the Danish Colorectal Cancer Screening program, is the largest randomized controlled trial to date on colon capsule endoscopy (CCE). This paper presents the interim analysis with the objective of ensuring the sa...

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Autores principales:	Ulrik Deding, Thomas Bjørsum-Meyer, Lasse Kaalby, Morten Kobaek-Larsen, Marianne Kirstine Thygesen, Jeppe Buur Madsen, Rasmus Kroijer, Gunnar Baatrup
Formato:	article
Lenguaje:	EN
Publicado:	Georg Thieme Verlag KG 2021
Materias:	Diseases of the digestive system. Gastroenterology RC799-869
Acceso en línea:	https://doaj.org/article/561525c2a4464360a12d5e37f51a8843
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spelling	oai:doaj.org-article:561525c2a4464360a12d5e37f51a88432021-11-13T00:00:31ZColon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon20152364-37222196-973610.1055/a-1546-8727https://doaj.org/article/561525c2a4464360a12d5e37f51a88432021-11-01T00:00:00Zhttp://www.thieme-connect.de/DOI/DOI?10.1055/a-1546-8727https://doaj.org/toc/2364-3722https://doaj.org/toc/2196-9736Background and study aims The Danish CareForColon2015 trial, launched in 2020 as part of the Danish Colorectal Cancer Screening program, is the largest randomized controlled trial to date on colon capsule endoscopy (CCE). This paper presents the interim analysis with the objective of ensuring the safety of patients in the intervention group and evaluating the clinical performance of the trial’s predefined clinical parameters. Patients and methods We evaluated the initial 234 CCEs according to quality, safety, and completion. The participation rates and preference distribution of all individuals invited were analyzed and sample size calculations were adjusted. Results Fecal immunochemical test and diagnostic participation rates were 62.1 % and 91.1 %, respectively. The completion rate for CCEs was 67.9 % and the rate of conclusive investigations was 80.3 %. The polyp detection rate (PDR) was high (73.5 %), only two (0.85 %) technical failures in 234 videos were observed, and six suspected cancers were identified (2.6 %). No major adverse events were recorded. The required number of invitations had been underestimated due to inaccurate assumptions in sample size calculations. Conclusions The trial was efficient and safe in terms of CCE quality and time to diagnostic investigation. Participation rates and PDRs were high. The proportion of suspected cancers was lower than expected and will be followed. The completion rate for CCEs was acceptable but lower than expected and the CCE procedure was reviewed for potential improvements and Resolor was added to the regime. The number of invitations for the intervention group of the trial has been adjusted from 62,107 to 185,153.Ulrik DedingThomas Bjørsum-MeyerLasse KaalbyMorten Kobaek-LarsenMarianne Kirstine ThygesenJeppe Buur MadsenRasmus KroijerGunnar BaatrupGeorg Thieme Verlag KGarticleDiseases of the digestive system. GastroenterologyRC799-869ENEndoscopy International Open, Vol 09, Iss 11, Pp E1712-E1719 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Diseases of the digestive system. Gastroenterology RC799-869
spellingShingle	Diseases of the digestive system. Gastroenterology RC799-869 Ulrik Deding Thomas Bjørsum-Meyer Lasse Kaalby Morten Kobaek-Larsen Marianne Kirstine Thygesen Jeppe Buur Madsen Rasmus Kroijer Gunnar Baatrup Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015
description	Background and study aims The Danish CareForColon2015 trial, launched in 2020 as part of the Danish Colorectal Cancer Screening program, is the largest randomized controlled trial to date on colon capsule endoscopy (CCE). This paper presents the interim analysis with the objective of ensuring the safety of patients in the intervention group and evaluating the clinical performance of the trial’s predefined clinical parameters. Patients and methods We evaluated the initial 234 CCEs according to quality, safety, and completion. The participation rates and preference distribution of all individuals invited were analyzed and sample size calculations were adjusted. Results Fecal immunochemical test and diagnostic participation rates were 62.1 % and 91.1 %, respectively. The completion rate for CCEs was 67.9 % and the rate of conclusive investigations was 80.3 %. The polyp detection rate (PDR) was high (73.5 %), only two (0.85 %) technical failures in 234 videos were observed, and six suspected cancers were identified (2.6 %). No major adverse events were recorded. The required number of invitations had been underestimated due to inaccurate assumptions in sample size calculations. Conclusions The trial was efficient and safe in terms of CCE quality and time to diagnostic investigation. Participation rates and PDRs were high. The proportion of suspected cancers was lower than expected and will be followed. The completion rate for CCEs was acceptable but lower than expected and the CCE procedure was reviewed for potential improvements and Resolor was added to the regime. The number of invitations for the intervention group of the trial has been adjusted from 62,107 to 185,153.
format	article
author	Ulrik Deding Thomas Bjørsum-Meyer Lasse Kaalby Morten Kobaek-Larsen Marianne Kirstine Thygesen Jeppe Buur Madsen Rasmus Kroijer Gunnar Baatrup
author_facet	Ulrik Deding Thomas Bjørsum-Meyer Lasse Kaalby Morten Kobaek-Larsen Marianne Kirstine Thygesen Jeppe Buur Madsen Rasmus Kroijer Gunnar Baatrup
author_sort	Ulrik Deding
title	Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015
title_short	Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015
title_full	Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015
title_fullStr	Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015
title_full_unstemmed	Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015
title_sort	colon capsule endoscopy in colorectal cancer screening: interim analyses of randomized controlled trial careforcolon2015
publisher	Georg Thieme Verlag KG
publishDate	2021
url	https://doaj.org/article/561525c2a4464360a12d5e37f51a8843
work_keys_str_mv	AT ulrikdeding coloncapsuleendoscopyincolorectalcancerscreeninginterimanalysesofrandomizedcontrolledtrialcareforcolon2015 AT thomasbjørsummeyer coloncapsuleendoscopyincolorectalcancerscreeninginterimanalysesofrandomizedcontrolledtrialcareforcolon2015 AT lassekaalby coloncapsuleendoscopyincolorectalcancerscreeninginterimanalysesofrandomizedcontrolledtrialcareforcolon2015 AT mortenkobaeklarsen coloncapsuleendoscopyincolorectalcancerscreeninginterimanalysesofrandomizedcontrolledtrialcareforcolon2015 AT mariannekirstinethygesen coloncapsuleendoscopyincolorectalcancerscreeninginterimanalysesofrandomizedcontrolledtrialcareforcolon2015 AT jeppebuurmadsen coloncapsuleendoscopyincolorectalcancerscreeninginterimanalysesofrandomizedcontrolledtrialcareforcolon2015 AT rasmuskroijer coloncapsuleendoscopyincolorectalcancerscreeninginterimanalysesofrandomizedcontrolledtrialcareforcolon2015 AT gunnarbaatrup coloncapsuleendoscopyincolorectalcancerscreeninginterimanalysesofrandomizedcontrolledtrialcareforcolon2015
_version_	1718430316739166208

Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015

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