Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study

Haroon M. Shahid, Romy Bareket, Amy Tyberg, Avik Sarkar, Alexa Simon, Krishna Gurram, Frank G. Gress, Prashant Bhenswala, Divya Chalikonda, David E. Loren, Thomas E. Kowalski, Anand Kumar, Ashley A. Vareedayah, Priya R. Abhyankar, Kasey Parker, Moamen M. Gabr, Jose Nieto, Rabia De Latour, Mitchelle Zolotarevsky, Jeremy BarberEugene Zolotarevsky, Enrique Vazquez-Sequeiros, Monica Gaidhane, Iman Andalib, Michel Kahaleh

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

Introduction: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. Methods: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. Results: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. Conclusions: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Original languageEnglish
Pages (from-to)798-803
Number of pages6
JournalJournal of Clinical Gastroenterology
Volume57
Issue number8
DOIs
StatePublished - Sep 24 2023
Externally publishedYes

Keywords

  • ASGE
  • ERCP
  • Single-use disposable
  • duodenoscope
  • infection
  • reusable duodenoscope
  • Humans
  • Middle Aged
  • Male
  • Cholangiopancreatography, Endoscopic Retrograde/adverse effects
  • Aged
  • Duodenoscopes/adverse effects

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