Systematic Reviews
Copyright ©The Author(s) 2022.
World J Methodol. May 20, 2022; 12(3): 122-131
Published online May 20, 2022. doi: 10.5662/wjm.v12.i3.122
Table 1 Characteristics of studies assessing the performance of single-use duodenoscope for endoscopic retrograde cholangiopancreatography
Region, Study design
Population (no.); male gender (%)
Age (yr, SD)
Naïve papilla (%)
ASGE complexity 3-4 (%)
Technical success (%)
Serious AEs (%)
Muthusamy et al[22], 2020United States, Case-seriesNo. 60, Male 61.7%64.4 ± 14.126.70%45.00%96.70%6.70%The study included a roll-in phase with 13 patients
Bang JY et al[23], 2020United States, RCTNo. 48, Male 54.2%67.2 ± 14.4100%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], 2022France, ProspectiveNo. 60, Male 43.3%65.5 ± 13.653.30%40.00%95%1.70%96.7% of cases with optimal operators’ satisfaction
Slivka et al[25], 2021United States, ProspectiveNo. 200, Male 48.5%62.6 ± 14.045.50%40.50%90.50%6.50%Included 14 expert and 5 “non-expert” ERCP operators with similar outcomes
Table 2 Summary of ongoing registered studies assessing the performance of single-use duodenoscope for American society for gastrointestinal endoscopy, registered on portal
Title, referenceRegionInvestigatorsDesign, population, DuodenoscopePrimary outcomeStatus
Single Use ERCP -SURE Study (SURE). NCT04671095Nottingham, United KingdomDr. Suresh Vasan Venkatachalapathy; suresh.venkatachalapathy@nuh.nhs.ukProspective, 50 patients, EXALT-D1Technical 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). NCT04712253Rozzano (MI), ItalyProf. Alessandro Repici; Dr. Andrea Anderloni andrea.anderloni@humanitas.itRetrospective, 50 patients, EXALT-D1Technical success, clinical outcomesRecruiting
Global Prospective Case Series Using a Single-Use Duodenoscope. NCT04103749United StatesGregory Tirrell;; Pooja Goswamy; pooja.goswamy@bsci.comProspective, 1000 patients, EXALT-D1Technical success (ERCP completion)Not yet recruiting
Exalt D Single-use Duodenoscope in ERCP Procedures in China (ExaltDScope). NCT04687774ChinaZhiwei; Jingjing GuObservational, 30 patients, EXALT-D1Technical success (ERCP completion)Not yet recruiting
A Single-Use Duodenoscope in a Real-World Setting. NCT04628949United StatesElizabeth Smith; elsm@ambu.comTrine; Højgaard Tølbøll; trht@ambu.comProspective, 550 patients, aScopeTechnical success (ERCP completion)Recruiting