Colon capsule endoscopy as possible filter test for colonoscopy selection in a screening population with positive fecal immunology
submitted 17. November 2013
accepted after revision 30. Januar 2014
13. Mai 2014 (online)
Background and study aims: Stool tests are highly useful in colorectal cancer (CRC) screening programs; however, they are not as specific as users would like, and place a major burden on resources and subject a number of patients to the risks of invasive optical colonoscopy unnecessarily. Colon capsule endoscopy (CCE) has the potential to reduce the need for optical colonoscopy. To date, the role of CCE in a fecal immunological test (FIT)-based CRC screening program has not been formally evaluated. The aims of this study were to assess the sensitivity, specificity, and negative and positive predictive values of CCE compared with optical colonoscopy in an FIT-positive CRC screening cohort.
Patients and methods: A prospective comparison study of CCE compared with optical colonoscopy was undertaken within the second round of a FIT-based bowel screening pilot. Participants with a positive FIT result were invited to undergo both CCE and optical colonoscopy. CCE was performed on Day 1 and optical colonoscopy was performed the following morning.
Results: A total of 62 participants were recruited. Optical colonoscopy detected at least one polyp in 36 participants (58 %), significant lesions in 18 (29 %), and cancer in 1 (2 %). There was good correlation between CCE and optical colonoscopy for any lesion and for significant lesions (r = 0.62 and 0.84, respectively). The negative predictive value of CCE was high both for any polyp (90 %) and for significant lesions (96 %).
Conclusions: CCE is a safe and effective means of detecting cancer and polyps in a positive FIT screening cohort. The results suggest that CCE would be a useful “filter test” in this situation, and would reduce the number of colonoscopies performed by 71 %.
- 1 Ferlay J, Parkin DM, Stelliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010; 46: 765-781
- 2 Coleman MP, Forman D, Bryant H et al. Cancer survival in Australia, Canada, Denmark, Norway, Sweden, and the UK, 1995–2007 (the International Cancer Benchmarking Partnership): an analysis of population-based cancer registry data. Lancet 2011; 377: 127-138
- 3 Towler B, Irwig L, Glasziou P et al. A systematic review of the effects of screening for colorectal cancer using the faecal occult blood test, hemoccult. BMJ 1998; 317: 559-565
- 4 Hewitson P, Glasziou P, Watson E et al. Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. Am J Gastroenterol 2008; 103: 1541-1549
- 5 von Karsa L, Patnick J, Segnan N. European Colorectal Cancer Screening Guidelines Working Group et al. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy 2013; 45: 51-59
- 6 Logan R, Patnick J, Nickerson C et al. Outcomes of the Bowel Cancer Screening Programme (BCSP) in England after the first 1 million tests. Gut 2012; 61: 1439-1446
- 7 Oort FA, Terhaar Sive Droste JS, Van Der Hulst RW et al. Colonoscopy-controlled intra-individual comparisons to screen relevant neoplasia: faecal immunochemical test vs. guaiac-based faecal occult blood test. Aliment Pharmacol Ther 2010; 31: 432-439
- 8 Zhu MM, Xu XT, Nie F et al. Comparison of immunochemical and guaiac-based fecal occult blood test in screening and surveillance for advanced colorectal neoplasms: a meta-analysis. J Dig Dis 2010; 11: 148-160
- 9 McNamara D, Qasim A, Lee N et al. Round one of the Adelaide and Meath Hospital/Trinity College Colorectal Cancer Screening Programme: programme report and analysis based on established international key performance indices. Ir J Med Sci 2011; 180: 549-552
- 10 Eliakim R, Fireman Z, Gralnek IM et al. Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study. Endoscopy 2006; 38: 963-970
- 11 Van Gossum A, Munoz-Navas M, Fernandez-Urien I et al. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med 2009; 361: 264-270
- 12 Spada C, De Vincentis F, Cesaro P et al. Accuracy and safety of second-generation PillCam COLON capsule for colorectal polyp detection. Therap Adv Gastroenterol 2012; 5: 173-178
- 13 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
- 14 Herrerías-Gutiérrez JM, Argüelles-Arias F, Caunedo-Álvarez A et al. PillCamColon Capsule for the study of colonic pathology in clinical practice. Study of agreement with colonoscopy. Rev Esp Enferm Dig 2011; 103: 69-75
- 15 Gay G, Delvaux M, Frederic M et al. Could the colonic capsule PillCam Colon be clinically useful for selecting patients who deserve a complete colonoscopy? results of clinical comparison with colonoscopy in the perspective of colorectal cancer screening. Am J Gastroenterol 2010; 105: 1076-1086
- 16 Sieg A, Friedrich K, Sieg U. Is PillCam COLON capsule endoscopy ready for colorectal cancer screening? A prospective feasibility study in a community gastroenterology practice. Am J Gastroenterol 2009; 104: 848-854
- 17 Spada C, Hassan C, Munoz-Navas M et al. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc 2011; 74: 581-589.e1
- 18 Spada C, Hassan C, Galmiche JP et al. Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2012; 44: 527-536
- 19 Spada C, Riccioni ME, Hassan C et al. PillCam colon capsule endoscopy: a prospective, randomized trial comparing two regimens of preparation. J Clin Gastroenterol 2011; 45: 119-124
- 20 Pilz JB, Portman S, Peter S et al. Colon capsule endoscopy compared to conventional colonoscopy under routine screening conditions. BMC Gastroenterol 2010; 10: 66
- 21 Groth S, Krause H, Behrendt H et al. Capsule colonoscopy increases uptake of colorectal cancer screening. BMC Gastroenterol 2012; 12: 80
- 22 Terhaar Sive Droste JS, Oort FA, van der Hulst RW et al. Higher fecal immunochemical test cutoff levels: lower positivity rates but still acceptable detection rates for early-stage colorectal cancers. Cancer Epidemiol Biomarkers Prev 2011; 20: 272-280
- 23 Hartmann D, Keuchel M, Philipper M et al. A pilot study evaluating a new low-volume colon cleansing procedure for capsule colonoscopy. Endoscopy 2012; 44: 482-486
- 24 Kakugawa Y, Saito Y, Saito S et al. New reduced volume preparation regimen in colon capsule endoscopy. World J Gastroenterol 2012; 18: 2092-2098
- 25 Spada C, Hassan C, Ingrosso M et al. A new regimen of bowel preparation for PillCam colon capsule endoscopy: a pilot study. Dig Liver Dis 2011; 43: 300-304