Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial

Abstract

Background and study aims Up to 25 % colorectal adenomas are missed during colonoscopy. The aim of this study was to investigate whether the endocuff could improve polyp detection in an organized bowel cancer screening program (BCSP).

Patients and methods This parallel group, single-blinded, randomized controlled trial included patients with positive fecal occult blood test (FOBT) who were attending for BCSP colonoscopy. The primary outcome was the number of polyps per patient. Secondary outcomes included the number of adenomas per patient, adenoma and polyp detection rates, and withdrawal times.

Results A total of 534 BCSP patients were randomized to endocuff-assisted or standard colonoscopy. The mean age was 67 years and the male to female ratio was 1.8:1. We detected no significant difference in the number of polyps per patient (standard 1.8, endocuff 1.6; P = 0.44), adenomas per patient (standard 1.4, endocuff 1.3; P = 0.54), polyp detection rate (standard 69.8 %, endocuff 70.3 %; P = 0.93), adenoma detection rate (standard 63.0 %, endocuff 60.9 %; P = 0.85), advanced adenoma detection rate (standard 18.5 %, endocuff 16.9 %; P = 0.81), and cancer detection rate (standard 5.7 %, endocuff 5.3 %; P = 0.85). The mean withdrawal time was significantly shorter among patients in the endocuff group compared with the standard colonoscopy group (16.9 vs. 19.5 minutes; P < 0.005). The endocuff had to be removed in 17/266 patients (6.4 %) because of inability to pass through the sigmoid colon.

Conclusions This study did not find improved polyp or adenoma detection with endocuff-assisted colonoscopy in the FOBT-positive BCSP population. A shorter withdrawal time with endocuff may reflect improved views and stability provided by the endocuff.

Trial registered at ClinicalTrials.gov (NCT02529007).

• References

• 1 Bowel cancer incidence statistics. Available from: www.cancerresearchuk.org/cancer-info/cancerstats/types/bowel/incidence/ Accessed 9 May 2017
• 2 Nishihara R, Wu K, Lochhead P. et al. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med 2013; 369: 1095-1105
• 3 Logan RF, 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
• 4 Pan J, Xin L, Ma YF. et al. Colonoscopy reduces colorectal cancer incidence and mortality in patients with non-malignant findings: a meta-analysis. Am J Gastroenterol 2016; 111: 355-365
• 5 Corley DA, Jensen CD, Marks AR. et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med 2014; 370: 1298-1306
• 6 Van Rijn JC, Reitsma JB, Stoker J. et al. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol 2006; 101: 343-350
• 7 Vavricka SR, Sulz MC, Degen L. et al. Monitoring colonoscopy withdrawal time significantly improves the adenoma detection rate and the performance of endoscopists. Endoscopy 2016; 48: 256-262
• 8 Rondonotti E, Zolk O, Amato A. et al. The impact of hyoscine-N-butylbromide on adenoma detection during colonoscopy: meta-analysis of randomized, controlled studies. Gastrointest Endosc 2014; 80: 1103-1112
• 9 Pasha SF, Leighton JA, Das A. et al. Comparison of the yield and miss rate of narrow band imaging and white light endoscopy in patients undergoing screening or surveillance colonoscopy: a meta-analysis. Am J Gastroenterol 2012; 107: 363-370
• 10 Gralnek IM, Siersema PD, Halpern Z. et al. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol 2014; 15: 353-360
• 11 Leufkens AM, DeMarco DC, Rastogi A. et al. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc 2011; 73: 480-489
• 12 Morgan J, Thomas K, Lee-Robichaud H. et al. Transparent cap colonoscopy versus standard colonoscopy to improve caecal intubation. Cochrane Database Syst Rev 2012; 12: CD008211
• 13 Floer M, Biecker E, Fitzlaff R. et al. Higher adenoma detection rates with endocuff-assisted colonoscopy – a randomized controlled multicenter trial. PLoS One 2014; 9: e114267
• 14 Van Doorn SC, van der Vlugt M, Depla A. et al. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicenter randomised controlled trial. Gut 2017; 66: 438-445
• 15 East JE, Bassett P, Arebi N. et al. Dynamic patient position changes during colonoscope withdrawal increase adenoma detection: a randomized, crossover trial. Gastrointest Endosc 2011; 73: 456-463
• 16 Rees CJ, Thomas Gibson S, Rutter MD. et al. UK key performance indicators and quality assurance standards for colonoscopy. Gut 2016; 65: 1923-1929
• 17 Ekkelenkamp VE, Dowler K, Valori RM. et al. Patient comfort and quality in colonoscopy. World J Gastroenterol 2013; 19: 2355-2361
• 18 Biecker E, Floer M, Heinecke A. et al. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol 2015; 49: 413-418
• 19 De Palma GD, Giglio MC, Bruzzese D. et al. Cap cuff-assisted colonoscopy versus standard colonoscopy for adenoma detection: a randomized back-to-back study. Gastrointest Endosc 2017; DOI: 10.1016/j.gie.2016.12.027.