1. Colon capsule versus computed tomography colonography for colorectal cancer screening in patients with positive fecal occult blood test who refuse colonoscopy: a randomized trial
- Author
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Frédéric Veniat, Julien Balique, Christine Chambon-Augoyard, M. G. Lapalus, Christell Ganne, Y Billaud, Luc Henry, Michel Bretagnolle, Romain Malezieux, Jean-Christophe Saurin, Léa Vecchiato, Antoine De Leusse, Jean-Charles Montoy, Olivia Scalone, Julien Marsot, Clémentine Gandilhon, Mathieu Pioche, Pierre-Jean Valette, Josiane Tomczyk-Ferrero, Antoine Detry, Patricia Soler-Michel, Emilie Del Tedesco, Annabel Taillandier, Benoit Russias, Thierry Ponchon, Alain Fond, Rodica Gincul, and Jin Qiu
- Subjects
Male ,medicine.medical_specialty ,Randomization ,Colonoscopy ,Capsule Endoscopy ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Computed Tomography Colonography ,Capsule endoscopy ,medicine ,Humans ,Early Detection of Cancer ,Aged ,medicine.diagnostic_test ,business.industry ,Fecal occult blood ,Gastroenterology ,Capsule ,Middle Aged ,Patient Acceptance of Health Care ,Clinical trial ,030220 oncology & carcinogenesis ,Occult Blood ,030211 gastroenterology & hepatology ,Female ,Radiology ,business ,Colorectal Neoplasms ,Colonography, Computed Tomographic - Abstract
Objective Some patients (10 % – 32 %) with a positive guaiac fecal occult blood test (gFOBT) do not undergo the recommended colonoscopy. The aim of this study was to compare video capsule endoscopy (VCE) and computed tomography colonography (CTC) in terms of participation rate and detection outcomes when offered to patients with a positive gFOBT who did not undergo the recommended colonoscopy. Methods An invitation letter offering CTC or VCE was sent to selected patients after randomization. Acceptance of the proposed (or alternative) procedure and procedure results were recorded. Sample size was evaluated according to the hypothesis of a 13 % increase of participation with VCE. Results A total of 756 patients were targeted. Following the invitation letter, 5.0 % (19/378) of patients underwent the proposed VCE and 7.4 % (28/378) underwent CTC, ( P = 0.18). Following the letter, 9.8 % (37/378) of patients in the VCE group underwent a diagnostic procedure (19 VCE, 1 CTC, 17 colonoscopy) vs. 10.8 % in the CTC group (41/378: 28 CTC, 13 colonoscopy; P = 0.55). There were more potentially neoplastic lesions diagnosed in the VCE group than in the CTC group (12/20 [60.0 %] vs. 8/28 [28.6 %]; P = 0.04). Thus, 15/20 noninvasive procedures in the VCE group (19 VCE, 1 CTC; 75.0 %) vs. 10/28 in the CTC group (35.7 %; P = 0.01) resulted in a recommendation of further colonoscopy, but only 10/25 patients actually underwent this proposed colonoscopy. Conclusion Patients with a positive gFOBT result who do not undergo the recommended colonoscopy are difficult to recruit to the screening program and simply proposing an additional, less-invasive procedure, such as VCE or CTC, is not an effective strategy. ClinicalTrials.govNCT02558881TRIAL REGISTRATION: Randomized, controlled trial NCT02558881 at clinicaltrials.gov.
- Published
- 2018