Endocuff-assisted colonoscopy is associated with a lower adenoma miss rate: a multicenter randomized tandem study

Abstract

Background and study aims The Endocuff (ARC Medical Design, Leeds, UK) is a device that, when mounted on the tip of an endoscope, may assist with inspection of a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. We aimed to compare the adenoma miss rates of Endocuff-assisted colonoscopy with those of conventional colonoscopy.

Patients and methods The included patients underwent same-day, back-to-back, (Endocuff-assisted colonoscopy as the index procedure followed by conventional colonoscopy or vice versa, randomly assigned 1:1) colonoscopies, performed by six endoscopists with documented adenoma detection rates > 35 %, in four tertiary endoscopy facilities.

Results We randomized 200 patients (mean age 61.2 years [standard deviation 9.8]; 86.5 % colorectal cancer screening surveillance cases). Overall, there were seven incomplete examinations using Endocuff and one with conventional colonoscopy (P = 0.03). Times for endoscope insertion (5.0 minutes [0.8 – 21.0] vs. 5.0 minutes [1.0 – 16.0]; P = 0.49) and withdrawal (6.0 minutes [3.2 – 29.0] vs. 6.0 minutes [3.1 – 17.0]; P = 0.06) were similar for Endocuff-assisted and conventional colonoscopy. We detected one cancer and 195 adenomas; 84 in the proximal colon. Endocuff-assisted colonoscopy showed significantly lower overall and proximal colon adenoma miss rates compared with conventional colonoscopy (14.7 % [8.0 % – 21.0 %] vs. 38.4 % [28.1 % – 48.6 %] and 10.4 % [1.8 % – 19.1 %] vs. 38.9 % [23.0 % – 54.8 %], respectively). No difference between the two arms was shown regarding advanced adenoma miss rates, either overall or in the proximal colon. There were no serious adverse events related to the procedures.

Conclusions In comparison with conventional colonoscopy, Endocuff-assisted colonoscopy has a significantly lower adenoma miss rate when performed by high-detector endoscopists. However, the incomplete colonoscopy rate with Endocuff is higher.

ClinicalTrials.gov Identifier: NCT02340065.

• References

• 1 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
• 2 Rex DK, Cutler CS, Lemmel GT. et al. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology 1997; 112: 24-28
• 3 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
• 4 Dik VK, Gralnek IM, Segol O. et al. Multicenter, randomized, tandem evaluation of EndoRings colonoscopy–results of the CLEVER study. Endoscopy 2015; 47: 1151-1158
• 5 Halpern Z, Gross SA, Gralnek IM. et al. Comparison of adenoma detection and miss rates between a novel balloon colonoscope and standard colonoscopy: a randomized tandem study. Endoscopy 2015; 47: 238-244
• 6 Gralnek IM. Emerging technological advancements in colonoscopy: Third Eye Retroscope and Third Eye Panoramic, Fuse Full Spectrum Endoscopy colonoscopy platform, Extra-Wide-Angle-View colonoscope, and NaviAid G-EYE balloon colonoscope. Dig Endosc 2014; 27: 223-231
• 7 Lenze F, Beyna T, Lenz P. et al. Endocuff-assisted colonoscopy: a new accessory to improve adenoma detection rate? Technical aspects and first clinical experiences. Endoscopy 2014; 46: 610-614
• 8 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
• 9 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
• 10 van Doorn SC, van der Vlugt M, Depla A. et al. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut 2017; 66: 438-445
• 11 Westwood DA, Alexakis N, Connor SJ. Evaluating cap-assisted colonoscopy: the relevance of study design. Gut 2012; 6: 1517
• 12 van den Broek FJ, Kuiper T, Dekker E. et al. Study designs to compare new colonoscopic techniques: clinical considerations, data analysis, and sample size calculations. Endoscopy 2013; 45: 922-927
• 13 Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc 2010; 72: 686-692
• 14 Winawer SJ, Zauber AG. The advanced adenoma as the primary target of screening. Gastrointest Endosc Clin N Am 2002; 12: 1-9
• 15 Hassan C, Quintero E, Dumonceau JM. et al. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2013; 45: 842-851
• 16 Lieberman DA, Rex DK, Winawer SJ. et al. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology 2012; 143: 844-857
• 17 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;
• 18 Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum 2012; 55: 218-225
• 19 Mir FA, Boumitri C, Ashraf I. et al. Cap-assisted colonoscopy versus standard colonoscopy: is the cap beneficial? A meta-analysis of randomized controlled trials. Gastrointest Endosc 2016; 83 (Suppl. 05) AB424
• 20 Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc 2010; 72: 775-781
• 21 Papanikolaou IS, Apostolopoulos P, Tziatzios G. et al. Lower adenoma miss rate with FUSE vs. conventional colonoscopy with proximal retroflexion: a randomized back-to-back trial. Endoscopy 2017; 49: 468-475