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].