Prospective evaluation of an assessment tool for technical performance of duodenoscopes

Ji Young Bang, Thomas Rösch, Hyungjin Myra Kim, Shyam Thakkar, Ernesto Robalino Gonzaga, Benjamin Tharian, Sumant Inamdar, Linda S. Lee, Patrick Yachimski, Priya Jamidar, Thiruvengadam Muniraj, Christopher DiMaio, Nikhil Kumta, Amrita Sethi, Peter Draganov, Dennis Yang, Talal Seoud, Abhilash Perisetti, Gayatri Bondi, Sachin KirtaneRobert Hawes, C. Mel Wilcox, Richard Kozarek, D. Nageshwar Reddy, Shyam Varadarajulu

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Objective: While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. Methods: An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach’s coefficient alpha (α). The secondary outcome was validity of the assessment tool. Results: The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach’s coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. Conclusions: The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.

Original languageEnglish
Pages (from-to)822-828
Number of pages7
JournalDigestive Endoscopy
Volume33
Issue number5
DOIs
StatePublished - Jul 2021

Keywords

  • duodenoscope
  • duodenoscope assessment tool
  • endoscopic retrograde cholangiopancreatography

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