Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography

Abstract

BACKGROUND & AIMS: Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). METHODS: We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events (assessed at 72 hours and 7 days). RESULTS: Thirteen (100%) roll-in maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization. CONCLUSIONS: In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958.

Use of a novel single-use disposable duodenoscope for ERCP: selected clips from a real-world case series

“…1 A preliminary case series was performed to demonstrate the feasibility and performance of a new single-use duodenoscope. 2 Videos of several key steps of ERCP obtained from 4 patients in this study are shown here to demonstrate that these steps can successfully be performed using the new device in a real-world setting (Video 1, available online at www.VideoGIE.org). All procedures were performed by a single expert endoscopist at our institution on patients who presented for ERCP for standard indications and who passed inclusion/exclusion criteria for the original study.…”

Duodenoscope-related infections and potential role of single-use duodenoscopes

“…To date, 15 cases have been done at our institution, with the majority as part of a previously published clinical study, including the case examples (Video 1), with this device. 6 In Video 1, 3 case examples of successful use of the single-use duodenoscope in common bile duct stone removal, biliary plastic stent placement, and single-operator cholangioscopy have been demonstrated.…”

“…Although there has been success with different complexities of ERCP cases, the operators performing these cases were expert endoscopists. 6 The success of ERCP with single-use duodenoscopes will need to be evaluated among early-career advanced endoscopists to establish whether there is a learning curve and whether that will affect the adverse events associated with ERCP. Furthermore, the environmental impact of single-use duodenoscopes will need to be evaluated.…”

“…5 Only a limited number of cases have been done to date; however, they have been successful in a wide array of cases. 6 At our institution, we have used this single-use duodenoscope as part of a clinical trial and for ERCP in patients with COVID-19 or those under investigation for COVID-19. Another single-use duodenoscope was recently approved by the Food and Drug Administration.…”

What are the needed criteria for the adoption of new technology aimed at preventing duodenoscope-transmitted infections?

“…Exorbitant costs notwithstanding, this disposable duodenoscope appears to function well in an ERCP model 5 , and limited clinical data suggest that routine ERCP maneuvers can be accomplished with a high degree of technical success. 6 In this issue of Gastrointestinal Endoscopy, Pasricha et al 7 describe an FDA-cleared disposable sheath device (ScopeSeal, GI Scientific, LLC, Arlington, Va, USA), which can be placed inside the working channel of an Olympus TJF-Q180V duodenoscope, the most common duodenoscope currently in use in the United States. ScopeSeal has the following key components: (1) an optical lens to cover the camera and light source, (2) a port to seal the Given the costs related to even one duodenoscope-transmitted infection, the disposable caps and ScopeSeal options seem reasonable in our current cost-conscious environment.…”