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Equivalent performance of single-use and reusable duodenoscopes in a randomised trial

Authors :
Shyam Varadarajulu
Ji Young Bang
Robert H. Hawes
Source :
Gut
Publication Year :
2020

Abstract

ObjectiveSingle-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use and reusable duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).DesignPatients with native papilla requiring ERCP were randomised to single-use or reusable duodenoscope. Primary outcome was comparing number of attempts to achieve successful cannulation of desired duct. Secondary outcomes were technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events.Results98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures. While median number of attempts to achieve successful cannulation was significantly lower for single-use cohort (2 vs 5, p=0.013), ease of passage into stomach (p=0.047), image quality (pConclusionGiven the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands.Trial registration numberClinicaltrials.gov number: NCT04143698

Details

ISSN :
14683288 and 04143698
Volume :
70
Issue :
5
Database :
OpenAIRE
Journal :
Gut
Accession number :
edsair.doi.dedup.....c6235c58f7f35db4f345ddce315dd799