IRCCS Humanitas Research Hospital & Humanitas University
Published January 15, 2024 | Version v1
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Dataset related to article "The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study"

Authors/Creators

  • 1. ROR icon IRCCS Humanitas Research Hospital
  • 2. Robert Wood Johnson University Hospital
  • 3. ROR icon University of California, Los Angeles
  • 4. Ospedale Giuseppe Mazzini, ASL Teramo
  • 5. ROR icon Borland Groover Clinic
  • 6. ROR icon King Fahd Medical City
  • 7. Rutgers Robert Wood Johnson Medical School
  • 8. Rutgers Robert Wood Johnson Medical School New Brunswick
  • 9. ROR icon Humanitas University
  • 10. Asian Institute of Gastroenterology, Hyderabad
  • 11. Fondazione IRCCS Policlinico San Matteo

Description

This record contains raw data related to article “The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study”

Background: Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy.

Methods: This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate.

Results: A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding.

Conclusions: Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

Keywords: Difficult biliary stones; Endoscopic retrograde cholangiopancreatography; Indeterminate biliary stricture; Single-operator cholangioscopy; Single-use duodenoscope.

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Related works

Is supplemented by
Publication: 10.1016/j.hbpd.2023.04.002 (DOI)
Publication: 37100688 (PMID)