Colon capsule versus computed tomography colonography for colorectal cancer screening in patients with positive fecal occult blood test who refuse colonoscopy: a randomized trialTRIAL REGISTRATION: Randomized, controlled trial 2012-A01294-39 at clinicaltrialsregister.eu.
submitted 11 August 2017
accepted after revision 19 December 2017
27 February 2018 (eFirst)
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.
- 1 Klabunde C, Blom J, Bulliard J-L. et al. Participation rates for organized colorectal cancer screening programmes: an international comparison. J Med Screen 2015; 22: 119-126
- 2 Liang PS, Wheat CL, Abhat A. et al. Adherence to competing strategies for colorectal cancer screening over 3 years. Am J Gastroenterol 2015; DOI: 10.1038/ajg.2015.367.
- 3 Lisi D, Hassan C, Crespi M. ; AMOD Study Group. Participation in colorectal cancer screening with FOBT and colonoscopy: an Italian, multicentre, randomized population study. Dig Liver Dis 2010; 42: 371-376
- 4 Goulard H, Boussac-Zarebska M, Ancelle-Park R. et al. French colorectal cancer screening pilot programme: results of the first round. J Med Screen 2008; 15: 143-148
- 5 Liss DT, Brown T, Lee JY. et al. Diagnostic colonoscopy following a positive fecal occult blood test in community health center patients. Cancer Causes Control 2016; 27: 881-887
- 6 Segnan N, Senore C, Andreoni B. et al. Randomized trial of different screening strategies for colorectal cancer: patient response and detection rates. J Natl Cancer Inst 2005; 97: 347-357
- 7 Manfredi S, Piette C, Durand G. et al. Colonoscopy results of a French regional FOBT-based colorectal cancer screening program with high compliance. Endoscopy 2008; 40: 422-427
- 8 Pohl J, Lotterer E, Balzer C. et al. Computed virtual chromoendoscopy versus standard colonoscopy with targeted indigocarmine chromoscopy: a randomised multicentre trial. Gut 2009; 58: 73-78
- 9 Haute Autorité de Santé. Coloscopie virtuelle. Méta-analyse des performances diagnostiques. Indications et conditions de réalisation. Available from: https://www.has-sante.fr/portail/jcms/c_923754/fr/coloscopie-virtuelle-meta-analyse-des-performances-diagnostiques-indications-et-conditions-de-realisation
- 10 Pioche M, de Leusse A, Filoche B. et al. Prospective multicenter evaluation of colon capsule examination indicated by colonoscopy failure or anesthesia contraindication. Endoscopy 2012; 44: 911-916
- 11 Spada C, Hassan C, Barbaro B. et al. Colon capsule versus CT colonography in patients with incomplete colonoscopy: a prospective, comparative trial. Gut 2015; 64: 272-281
- 12 Spada C, Hassan C, Marmo R. et al. Meta-analysis shows colon capsule endoscopy is effective in detecting colorectal polyps. Clin Gastroenterol Hepatol 2010; 8: 516-522
- 13 Spada C, Pasha SF, Gross SA. et al. Accuracy of first- and second-generation colon capsules in endoscopic detection of colorectal polyps: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2016; 14: 1533-1543.e8
- 14 Toes-Zoutendijk E, van Leerdam ME, Dekker E. et al. Real-time monitoring of results during first year of Dutch Colorectal Cancer Screening Program and optimization by altering fecal immunochemical test cut-off levels. Gastroenterology 2017; 152: 767-775.e2
- 15 Cheng S-Y, Li M-C, Chia S-L. et al. Factors affecting compliance with confirmatory colonoscopy after a positive fecal immunochemical test in a national colorectal screening program. Cancer 2017; DOI: 10.1002/cncr.31145.
- 16 Selby K, Baumgartner C, Levin TR. et al. Interventions to improve follow-up of positive results on fecal blood tests: a systematic review. Ann Intern Med 2017; 167: 565-575
- 17 Carlson CM, Kirby KA, Casadei MA. et al. Lack of follow-up after fecal occult blood testing in older adults: inappropriate screening or failure to follow up?. Arch Intern Med 2011; 171: 249-256
- 18 Denis B, Broc G, Sauleau EA. et al. Tailored telephone counselling to increase participation of underusers in a population-based colorectal cancer-screening programme with faecal occult blood test: a randomized controlled trial. Rev Epidemiol Sante Publique 2017; 65: 17-28
- 19 Segnan N, Senore C, Andreoni B. et al. Randomized trial of different screening strategies for colorectal cancer: patient response and detection rates. J Natl Cancer Inst 2005; 97: 347-357
- 20 Spada C, Hassan C, Barbaro B. et al. Colon capsule versus CT colonography in patients with incomplete colonoscopy: a prospective, comparative trial. Gut 2015; 64: 272-281
- 21 Theis J, Kim DH, Lubner MG. et al. CT colonography after incomplete optical colonoscopy: bowel preparation quality at same-day vs. deferred examination. Abdom Radiol N Y 2016; 41: 10-18
- 22 Lawrence EM, Pickhardt PJ. Low-volume hybrid bowel preparation combining saline laxatives with oral contrast agents versus standard polyethylene glycol lavage for colonoscopy. Dis Colon Rectum 2010; 53: 1176-1181
- 23 Sirakov NV, Velkova KG, Nikolov RR. et al. Improvement of visualization in computed tomographic colonography after mechanic air insufflation. Folia Med (Plovdiv) 2006; 48: 46-49