Endoscopy 2015; 47(12): 1151-1158
DOI: 10.1055/s-0034-1392421
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Multicenter, randomized, tandem evaluation of EndoRings colonoscopy – results of the CLEVER study

Vincent K. Dik
1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
Ian M. Gralnek
2   Institute of Gastroenterology and Liver Diseases, Ha’Emek Medical Center, Afula, Israel
3   GI Endoscopy Unit, Elisha Hospital, Haifa, Israel
4   Rappaport Family Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
Ori Segol
3   GI Endoscopy Unit, Elisha Hospital, Haifa, Israel
5   Department of Gastroenterology, Lady Davis Carmel Medical Center, Haifa, Israel
Alain Suissa
3   GI Endoscopy Unit, Elisha Hospital, Haifa, Israel
6   Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel
Tim D. G. Belderbos
1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
Leon M. G. Moons
1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
Meytal Segev
7   EndoAid Ltd., Caesarea, Israel
Sveta Domanov
3   GI Endoscopy Unit, Elisha Hospital, Haifa, Israel
Douglas K. Rex
8   Department of Medicine, Division of Gastroenterology and Hepatology, Indiana University Hospital, Indianapolis, IN, United States
Peter D. Siersema
1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
› Author Affiliations
Further Information

Publication History

submitted 24 January 2015

accepted after revision 29 April 2015

Publication Date:
28 July 2015 (online)

Background and study aims: Adenoma miss rate during colonoscopy has become a widely acknowledged proxy measure for post-colonoscopy colorectal cancer. Among other reasons, this can happen because of inadequate visualization of the proximal aspects of colonic folds and flexures. EndoRings (EndoAid Ltd., Caesarea, Israel) is a silicone-rubber device that is fitted onto the distal end of the colonoscope. Its flexible circular rings engage and mechanically stretch colonic folds during withdrawal. The primary aim of this study was to compare adenoma miss rates between standard colonoscopy and colonoscopy using EndoRings.

Methods: In this multicenter, randomized, tandem colonoscopy study, we performed same-day, back-to-back colonoscopies with EndoRings followed by standard colonoscopy, or vice versa.

Results: After exclusion of 10 patients for protocol violations, 116 patients (38.8 % female; mean age 58.7) remained for analysis. The adenoma miss rate of EndoRings colonoscopy (7/67; 10.4 %) was significantly lower (P < 0.001) compared with standard colonoscopy (28/58; 48.3 %). Similar results were found for polyp miss rates: EndoRings (9.1 %) and standard colonoscopy (52.8 %; P < 0.001). Mean cecal intubation times (9.3 vs. 8.4 minutes; P = 0.142) and withdrawal times (7.4 vs. 7.2 minutes; P = 0.286), respectively, were not significantly different between EndoRings and standard colonoscopy. Mean total procedure time was longer with EndoRings than with standard colonoscopy (21.6 vs. 18.5 minutes, P = 0.001) as more polyps were removed.

Conclusions: This study demonstrates that colonoscopy with EndoRings has lower adenoma and polyp miss rates than standard colonoscopy, which may improve the efficacy particularly of screening and surveillance colonoscopies.

ClinicalTrials.gov NCT01955122.

Table e4, e6

  • References

  • 1 Atkin WS, Valori R, Kuipers EJ et al. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition–Colonoscopic surveillance following adenoma removal. Endoscopy 2012; 44: SE151-SE163
  • 2 Lieberman DA, Weiss DG, Bond JH et al. Use of colonoscopy to screen asymptomatic adults for colorectal cancer. Veterans Affairs Cooperative Study Group 380. NEJM 2000; 343: 162-168
  • 3 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
  • 4 Regula J, Rupinski M, Kraszewska E et al. Colonoscopy in colorectal-cancer screening for detection of advanced neoplasia. NEJM 2006; 355: 1863-1872
  • 5 Baxter NN, Goldwasser MA, Paszat LF et al. Association of colonoscopy and death from colorectal cancer. Ann Intern Med 2009; 150: 1-8
  • 6 Cottet V, Jooste V, Fournel I et al. Long-term risk of colorectal cancer after adenoma removal: a population-based cohort study. Gut 2012; 61: 1180-1186
  • 7 Kahi CJ, Imperiale TF, Juliar BE et al. Effect of screening colonoscopy on colorectal cancer incidence and mortality. Clin Gastroenterol Hepatol 2009; 7: 770-775
  • 8 le Clercq CM, Bouwens MW, Rondagh EJ et al. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut 2014; 63: 957-963
  • 9 Robertson DJ, Lieberman DA, Winawer SJ et al. Colorectal cancers soon after colonoscopy: a pooled multicohort analysis. Gut 2013; 63: 949-956
  • 10 Zauber AG, Winawer SJ, O’Brien MJ et al. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. NEJM 2012; 366: 687-696
  • 11 Pohl H, Robertson DJ. Colorectal cancers detected after colonoscopy frequently result from missed lesions. Clin Gastroenterol Hepatol 2010; 8: 858-864
  • 12 Pickhardt PJ, Choi JR, Hwang I et al. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. NEJM 2003; 349: 2191-2200
  • 13 Pickhardt PJ, Nugent PA, Mysliwiec PA et al. Location of adenomas missed by optical colonoscopy. Ann Intern Med 2004; 141: 352-359
  • 14 East JE, Saunders BP, Burling D et al. Surface visualization at CT colonography simulated colonoscopy: effect of varying field of view and retrograde view. Am J Gastroenterol 2007; 102: 2529-2535
  • 15 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
  • 16 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
  • 17 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
  • 18 Rex DK, Petrini JL, Baron TH et al. Quality indicators for colonoscopy. Gastrointest Endosc 2006; 63: S16-S28
  • 19 Ng SC, Tsoi KK, Hirai HW et al. The efficacy of cap-assisted colonoscopy in polyp detection and cecal intubation: a meta-analysis of randomized controlled trials. Am J Gastroenterol 2012; 107: 1165-1173
  • 20 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
  • 21 Dik VK, Moons LM, Siersema PD. Endoscopic innovations to increase the adenoma detection rate during colonoscopy. World J Gastroenterol 2014; 20: 2200-2211
  • 22 Rex DK, Bond JH, Winawer S et al. Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol 2002; 97: 1296-1308
  • 23 Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc 2010; 72: 686-692
  • 24 Lai EJ, Calderwood AH, Doros G et al. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc 2009; 69: 620-625
  • 25 Mamula P, Tierney WM, Banerjee S et al. Devices to improve colon polyp detection. Gastrointest Endosc 2011; 73: 1092-1097
  • 26 Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc 2010; 72: 775-781
  • 27 Matsushita M, Hajiro K, Okazaki K et al. Efficacy of total colonoscopy with a transparent cap in comparison with colonoscopy without the cap. Endoscopy 1998; 30: 444-447
  • 28 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
  • 29 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
  • 30 Bressler B, Paszat LF, Vinden C et al. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology 2004; 127: 452-456
  • 31 Singh H, Nugent Z, Demers AA et al. The reduction in colorectal cancer mortality after colonoscopy varies by site of the cancer. Gastroenterology 2010; 139: 1128-1137
  • 32 Brenner H, Hoffmeister M, Arndt V et al. Protection from right- and left-sided colorectal neoplasms after colonoscopy: population-based study. J Natl Cancer Inst 2010; 102: 89-95
  • 33 Baxter NN, Warren JL, Barrett MJ et al. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol 2012; 30: 2664-2669