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. 2020 Mar 12;20(1):64.
doi: 10.1186/s12876-020-01200-7.

Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial

Nauzer Forbes  1   2 , B Joseph Elmunzer  3 , Thibault Allain  4 , Millie Chau  5 , Hannah F Koury  6 , Sydney Bass  5 , Paul J Belletrutti  5 , Martin J Cole  5 , Emmanuel Gonzalez-Moreno  5   7 , Ahmed Kayal  5   7 , Puja Kumar  5 , Rachid Mohamed  5 , Christian Turbide  5 , Andre G Buret  4 , Steven J Heitman  5   7
Affiliations

Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial

Nauzer Forbes et al. BMC Gastroenterol. .

Abstract

Background: Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized endoscopes used to perform ERCP, and inherent to their design, a high rate of persistent bacterial contamination exists even after automated reprocessing and disinfection. Consequently, in recent years, ERCP has been associated with infection transmission, leading to several fatal patient outbreaks. Due to increasing fears over widespread future duodenoscope-related outbreaks, regulatory bodies have called for alterations in the design of duodenoscopes. A duodenoscope has recently been developed that employs a disposable cap. This novel design theoretically eliminates the mechanism behind persistent bacterial contamination and infection transmission. However, there are no data demonstrating persistent bacterial contamination rates, technical success rates, or clinical outcomes associated with these duodenoscopes.

Methods: A parallel arm randomized controlled trial will be performed for which 520 patients will be recruited. The study population will consist of consecutive patients undergoing ERCP procedures for any indication at a high-volume tertiary care centre in Calgary, Alberta, Canada. Patients will be randomized to an intervention group, that will undergo ERCP with a novel duodenoscope with disposable cap, or to a control group who will undergo ERCP with a traditional duodenoscope. Co-primary outcomes will include persistent bacterial contamination rates (post automated reprocessing) and ERCP technical success rates. Secondary outcomes include clinical success rates, overall and specific early and late adverse event rates, 30-day mortality and healthcare utilization rates, procedure and reprocessing times, and ease of device use.

Discussion: The ICECAP trial will answer important questions regarding the use of a novel duodenoscope with disposable cap. Specifically, persistent bacterial contamination, technical performance, and relevant clinical outcomes will be assessed. Given the mortality and morbidity burden associated with ERCP-related infectious outbreaks, the results of this study have the capacity to be impactful at an international level.

Trial registration: This trial was registered on clinicaltrials.gov (NCT04040504) on July 31, 2019.

Keywords: Duodenoscopes; ERCP; Infection control; Sepsis.

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Conflict of interest statement

Nauzer Forbes has received speaker’s honoraria and research funding from Pentax Canada. No funding was received to support this study.

Figures

Fig. 1
Fig. 1
a ED34-i10T duodenoscope and b ED34-i10T2 duodenoscope with DEC™ [18, 19]
Fig. 2
Fig. 2
SPIRIT schedule of enrolment, interventions and assessments [16, 17]
See this image and copyright information in PMC

References

    1. Maple JT, Ikenberry SO, Anderson MA, Appalaneni V, Decker GA, Early D, Evans JA, Fanelli RD, Fisher D, Fisher L, et al. The role of endoscopy in the management of choledocholithiasis. Gastrointest Endosc. 2011;74(4):731–744. doi: 10.1016/j.gie.2011.04.012. - DOI - PubMed
    1. Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, et al. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005;62(1):1–8. doi: 10.1016/j.gie.2005.04.015. - DOI - PubMed
    1. Anderson MA, Appalaneni V, Ben-Menachem T, Decker GA, Early DS, Evans JA, Fanelli RD, Fisher DA, Fisher LR, Fukami N, et al. The role of endoscopy in the evaluation and treatment of patients with biliary neoplasia. Gastrointest Endosc. 2013;77(2):167–174. doi: 10.1016/j.gie.2012.09.029. - DOI - PubMed
    1. Chandrasekhara V, Chathadi KV, Acosta RD, Decker GA, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fanelli RD, Fisher DA, et al. The role of endoscopy in benign pancreatic disease. Gastrointest Endosc. 2015;82(2):203–214. doi: 10.1016/j.gie.2015.04.022. - DOI - PubMed
    1. Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, et al. Adverse events associated with ERCP. Gastrointest Endosc. 2017;85(1):32–47. doi: 10.1016/j.gie.2016.06.051. - DOI - PubMed

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