Single-use duodenoscopes for the prevention of endoscopic retrograde cholangiopancreatography -related cross-infection – from bench studies to clinical evidence

Table 1 Characteristics of studies assessing the performance of single-use duodenoscope for endoscopic retrograde cholangiopancreatography

Ref.	Region, Study design	Population (no.); male gender (%)	Age (yr, SD)	Naïve papilla (%)	ASGE complexity 3-4 (%)	Technical success (%)	Serious AEs (%)	Note
Muthusamy et al[22], 2020	United States, Case-series	No. 60, Male 61.7%	64.4 ± 14.1	26.70%	45.00%	96.70%	6.70%	The study included a roll-in phase with 13 patients
Bang JY et al[23], 2020	United States, RCT	No. 48, Male 54.2%	67.2 ± 14.4	100%	16.70%	SUD: 95.8%; Reusable: 100%	4.20%	Primary outcome was no. attempts to achieve cannulation (SUD median 2; reusable 5; P = 0.013)
Napoléon et al[24], 2022	France, Prospective	No. 60, Male 43.3%	65.5 ± 13.6	53.30%	40.00%	95%	1.70%	96.7% of cases with optimal operators’ satisfaction
Slivka et al[25], 2021	United States, Prospective	No. 200, Male 48.5%	62.6 ± 14.0	45.50%	40.50%	90.50%	6.50%	Included 14 expert and 5 “non-expert” ERCP operators with similar outcomes

ASGE: American society for gastrointestinal endoscopy; AEs: Adverse events; SD: Standard deviation; SUD: Single-use duodenoscope; RCT: Randomized controlled trial. ASGE complexity score refers to Cotton PB, Eisen G, Romagnuolo J, Vargo J, Baron T, Tarnasky P, Schutz S, Jacobson B, Bott C, Petersen B. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc 2011; 73: 868-874 [PMID: 21377673 DOI: 10.1016/j.gie.2010.12.036].

Table 2 Summary of ongoing registered studies assessing the performance of single-use duodenoscope for American society for gastrointestinal endoscopy, registered on clinicaltrial.gov portal

Title, reference	Region	Investigators	Design, population, Duodenoscope	Primary outcome	Status
Single Use ERCP -SURE Study (SURE). NCT04671095	Nottingham, United Kingdom	Dr. Suresh Vasan Venkatachalapathy; suresh.venkatachalapathy@nuh.nhs.uk	Prospective, 50 patients, EXALT-D1	Technical success (ERCP completion)	Not yet recruiting
International Study to Evaluate Outcomes and Safety of Patients Undergoing ERCP Using a Single-use Cholangioscope and Single-use Duodenoscope (MESE). NCT04712253	Rozzano (MI), Italy	Prof. Alessandro Repici alessandro.repici@hunimed.eu; Dr. Andrea Anderloni andrea.anderloni@humanitas.it	Retrospective, 50 patients, EXALT-D1	Technical success, clinical outcomes	Recruiting
Global Prospective Case Series Using a Single-Use Duodenoscope. NCT04103749	United States	Gregory Tirrell; gregory.tirrell@bsci.com; Pooja Goswamy; pooja.goswamy@bsci.com	Prospective, 1000 patients, EXALT-D1	Technical success (ERCP completion)	Not yet recruiting
Exalt D Single-use Duodenoscope in ERCP Procedures in China (ExaltDScope). NCT04687774	China	Zhiwei Guzhiwei.gu@bsci.com; Jingjing Gu	Observational, 30 patients, EXALT-D1	Technical success (ERCP completion)	Not yet recruiting
A Single-Use Duodenoscope in a Real-World Setting. NCT04628949	United States	Elizabeth Smith; elsm@ambu.comTrine; Højgaard Tølbøll; trht@ambu.com	Prospective, 550 patients, aScope	Technical success (ERCP completion)	Recruiting

¹EXALT-D is manufactured by Boston Scientific (MA, United States). The aScope™ Duodeno is manufactured by Ambu A/S (Denmark). ASGE: American Society for Gastrointestinal Endoscopy.