Endocuff vision-assisted vs. standard polyp resection in the colorectum (the EVASTA study): a prospective randomized studyTRIAL REGISTRATION: Prospective randomized study NCT03117114 at clinicaltrials.gov
submitted 10 March 2019
accepted after revision 10 September 2019
15 October 2019 (online)
Background Cap-assisted colonoscopy is frequently used to facilitate adenoma detection during endoscopy. However, data on how cap assistance influences polyp resection are scarce. We aimed to evaluate the impact of cap assistance with the Endocuff vision device (EVD) on the resection time for colorectal polyps in patients undergoing colonoscopy.
Methods A randomized, prospective study was performed in a university hospital in Germany. A total of 250 patients were randomly assigned 1:1 to undergo either colonoscopy with the EVD (EVD arm) or standard colonoscopy without the use of a cap (standard arm). The primary outcome was the average duration of polypectomy. Secondary outcomes included adenoma detection rate, cecal and ileal intubation times, and propofol dosage.
Results The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively; P = 0.02). This effect was strongest for polyps ≥ 6 mm. Compared with the standard group, Endocuff assistance also resulted in a shorter cecal intubation time (6 vs. 8 minutes; P = 0.03) and overall colonoscopy time (23 vs. 27 minutes; P = 0.02). In contrast, no difference in withdrawal time was observed. The polyp and adenoma detection rates did not differ significantly between the two groups.
Conclusion Endocuff-assisted colonoscopy reduces the duration of polypectomy, which may be due to a more stable scope position during resection. Further studies are needed to investigate whether comparable effects will be seen for other interventions, such as clipping or biopsy sampling.
- 1 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
- 2 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 2018; 87: 232-240
- 3 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
- 4 Ngu WS, Bevan R, Tsiamoulos ZP. et al. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut 2019; 68: 280-288
- 5 Williet N, Tournier Q, Vernet C. et al. Effect of Endocuff-assisted colonoscopy on adenoma detection rate: meta-analysis of randomized controlled trials. Endoscopy 2018; 50: 846-860
- 6 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
- 7 Klare P, Phlipsen H, Haller B. et al. Longer observation time increases adenoma detection in the proximal colon - a prospective study. Endosc Int Open 2017; 5: E1289-E1298
- 8 Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. Chichester, England: Wiley; 2010
- 9 Brenner H, Stock C, Hoffmeister M. Effect of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality: systematic review and meta-analysis of randomised controlled trials and observational studies. BMJ 2014; 348: g2467
- 10 Lauby-Secretan B, Vilahur N, Bianchini F. et al. The IARC perspective on colorectal cancer screening. NEJM 2018; 378: 1734-1740
- 11 Brenner H, Altenhofen L, Kretschmann J. et al. Trends in adenoma detection rates during the first 10 years of the German Screening Colonoscopy Program. Gastroenterology 2015; 149: 356-366 e351
- 12 Starker A, Buttmann-Schweiger N, Kraywinkel K. et al. Inanspruchnahme der Darmspiegelung in Deutschland. J Health Monitoring 2017; 2
- 13 Kang H, Thoufeeq MH. Size of colorectal polyps determines time taken to remove them endoscopically. Endosc Int Open 2018; 6: E610-E615
- 14 Tang Z, Zhang DS, Thrift AP. et al. Impact of cap-assisted colonoscopy on the learning curve and quality in colonoscopy: a randomized controlled trial. Gastrointest Endosc 2018; 87: 723-732 e723