Equivalent performance of single-use and reusable duodenoscopes in a randomised trial
Ji Young Bang, Robert Hawes, Shyam Varadarajulu, Ji Young Bang, Robert Hawes, Shyam Varadarajulu
Abstract
Objective: Single-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).
Design: Patients 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.
Results: 98 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 (p<0.001), image stability (p<0.001) and air-water button functionality (p<0.001) were significantly worse. There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts. On multivariate logistic regression analysis, only duodenoscope type (single-use) was associated with less than six attempts to achieve selective cannulation (p=0.012), when adjusted for patient demographics, procedural complexity and type of intervention.
Conclusion: Given 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 number: Clinicaltrials.gov number: NCT04143698.
Keywords: endoscopic retrograde pancreatography; therapeutic endoscopy.
Conflict of interest statement
Competing interests: JYB: Consultant for Olympus America Inc, Boston Scientific Corporation. SV: Consultant for Boston Scientific Corporation, Olympus America Inc, Covidien, Creo Medical. RH: Consultant for Boston Scientific Corporation, Olympus America Inc, Covidien, Creo Medical, Nine Points Medical, Cook Medical.
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Figures
References
- Rauwers AW, Voor In 't Holt AF, Buijs JG, et al. . High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut 2018;67:1637–45. 10.1136/gutjnl-2017-315082
- Kim S, Russell D, Mohamadnejad M, et al. . Risk factors associated with the transmission of carbapenem-resistant Enterobacteriaceae via contaminated duodenoscopes. Gastrointest Endosc 2016;83:1121–9. 10.1016/j.gie.2016.03.790
- Verfaillie CJ, Bruno MJ, Voor in 't Holt AF, et al. . Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa. Endoscopy 2015;47:493–502. 10.1055/s-0034-1391886
- Ross AS, Baliga C, Verma P, et al. . A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli. Gastrointest Endosc 2015;82:477–83. 10.1016/j.gie.2015.04.036
- Naryzhny I, Silas D, Chi K. Impact of ethylene oxide gas sterilization of duodenoscopes after a carbapenem-resistant Enterobacteriaceae outbreak. Gastrointest Endosc 2016;84:259–62. 10.1016/j.gie.2016.01.055
- US Food and Drug Administration: Medical Devices; Medical Device Safety; Safety Communications . The FDA continues to remind facilities of the importance of following duodenoscope reprocessing instructions: FDA safety communication, 2019. Available: [Accessed 12 Apr 2019].
- ASGE Standards of Practice Committee, Khashab MA, Chithadi KV, et al. . Antibiotic prophylaxis for Gi endoscopy. Gastrointest Endosc 2015;81:81–9. 10.1016/j.gie.2014.08.008
- Bang JY, Rösch T, Robalino Gonzaga ES, et al. . Su1513 technical evaluation of duodenoscope performance using a newly developed assessment tool. Gastrointest Endosc 2020;91:AB358. 10.1016/j.gie.2020.03.2228
- Cotton PB, Eisen G, Romagnuolo J, et al. . Grading the complexity of endoscopic procedures: results of an ASGE Working Party. Gastrointest Endosc 2011;73:868–74. 10.1016/j.gie.2010.12.036
- Chandrasekhara V, Khashab MA, Muthusamy VR, et al. . Adverse events associated with ERCP. Gastrointest Endosc 2017;85:32–47. 10.1016/j.gie.2016.06.051
- NIH . National cancer Institute common terminology criteria for adverse events (CTCAE) v5.0. Available:
- Elmunzer BJ, Serrano J, Chak A, et al. . Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial. Trials 2016;17:120. 10.1186/s13063-016-1251-2
- Testoni PA, Mariani A, Aabakken L, et al. . Papillary cannulation and sphincterotomy techniques at ERCP: European Society of gastrointestinal endoscopy (ESGE) clinical guideline. Endoscopy 2016;48:657–83. 10.1055/s-0042-108641
- Liao W-C, Angsuwatcharakon P, Isayama H, et al. . International consensus recommendations for difficult biliary access. Gastrointest Endosc 2017;85:295–304. 10.1016/j.gie.2016.09.037
- Buxbaum J, Leonor P, Tung J, et al. . Randomized trial of Endoscopist-Controlled vs. Assistant-Controlled wire-guided cannulation of the bile duct. Am J Gastroenterol 2016;111:1841–7. 10.1038/ajg.2016.268
- Hosmer DW, Lemeshow S, Sturdivant RX. Applied logistic regression. 3rd edn. John Wiley & Sons Inc., 2013.
- Afifi A, May S, Donatello RA, et al. . Practical multivariate analysis. 6th edn. Taylor & Francis Group, LLC, 2020.
- Montori VM, Guyatt GH. Intention-To-Treat principle. CMAJ 2001;165:1339–41.
- Sedgwick P. Intention to treat analysis versus per protocol analysis of trial data. BMJ 2015;350:h681. 10.1136/bmj.h681
- Rauwers AW. Voor In 't Holt AF, Buijs JG, et al. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut 2018;67:1637–45.
- Alrabaa SF, Nguyen P, Sanderson R, et al. . Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. Am J Infect Control 2013;41:562–4. 10.1016/j.ajic.2012.07.008
- Bang JY, Sutton B, Hawes R, et al. . Concept of disposable duodenoscope: at what cost? Gut 2019;68:1915–7. 10.1136/gutjnl-2019-318227
Source: PubMed