A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial.

Autor: Rex DK; Indiana University School of Medicine, Indianapolis, Indiana, USA., Sagi SV; Indiana University School of Medicine, Indianapolis, Indiana, USA., Kessler WR; Indiana University School of Medicine, Indianapolis, Indiana, USA., Rogers NA; Indiana University School of Medicine, Indianapolis, Indiana, USA., Fischer M; Indiana University School of Medicine, Indianapolis, Indiana, USA., Bohm ME; Indiana University School of Medicine, Indianapolis, Indiana, USA., Dewitt JM; Indiana University School of Medicine, Indianapolis, Indiana, USA., Lahr RE; Indiana University School of Medicine, Indianapolis, Indiana, USA., Searight MP; Indiana University School of Medicine, Indianapolis, Indiana, USA., Sullivan AW; Indiana University School of Medicine, Indianapolis, Indiana, USA., McWhinney CD; Indiana University School of Medicine, Indianapolis, Indiana, USA., Garcia JR; Indiana University School of Medicine, Indianapolis, Indiana, USA., Broadley HM; Indiana University School of Medicine, Indianapolis, Indiana, USA., Vemulapalli KC; Indiana University School of Medicine, Indianapolis, Indiana, USA.
Jazyk: angličtina
Zdroj: Gastrointestinal endoscopy [Gastrointest Endosc] 2019 Nov; Vol. 90 (5), pp. 835-840.e1. Date of Electronic Publication: 2019 Jul 15.
DOI: 10.1016/j.gie.2019.06.046
Abstrakt: Background and Aims: Endocuff (Arc Medical Design, Leeds, UK) and Endocuff Vision (Arc Medical Design, Leeds, UK) are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE (Medivators Inc, Minneapolis, Minn, USA) is a device that appears similar to the Endocuff devices but has received minimal clinical testing.
Methods: We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE.
Results: The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (standard deviation 2.83) versus 1.51 (2.29) with Endocuff Vision (P = .535). The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (P = .008). There was no difference between the arms for mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, P = .042).
Conclusions: AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision on which device to use can be based on cost. Additional comparisons of AmplifEYE with Endocuff by other investigators are warranted. (Clinical trial registration number: NCT03560128.).
(Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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