Ji Young Bang1, Thomas Rösch2, Hyungjin Myra Kim3, Shyam Thakkar4, Ernesto Robalino Gonzaga1, Benjamin Tharian5, Sumant Inamdar5, Linda S Lee6, Patrick Yachimski7, Priya Jamidar8, Thiruvengadam Muniraj8, Christopher DiMaio9, Nikhil Kumta9, Amrita Sethi10, Peter Draganov11, Dennis Yang11, Talal Seoud4, Abhilash Perisetti5, Gayatri Bondi6, Sachin Kirtane1, Robert Hawes1, C Mel Wilcox12, Richard Kozarek13, D Nageshwar Reddy14, Shyam Varadarajulu1. 1. Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida, USA. 2. Division of Gastroenterology & Hepatology, University Medical Center Hamburg - Eppendorf, Hamburg, Germany. 3. Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA. 4. Allegheny Health Network, Pittsburgh, Pennsylvania, USA. 5. Division of Gastroenterology & Hepatology, University of Arkansas, Little Rock, Arkansas, USA. 6. Division of Gastroenterology & Hepatology, Brigham & Women's Hospital, Boston, Massachusetts, USA. 7. Division of Gastroenterology & Hepatology, Vanderbilt University, Nashville, Tennessee, USA. 8. Division of Gastroenterology & Hepatology, Yale University, New Haven, Connecticut, USA. 9. Division of Gastroenterology & Hepatology, Mount Sinai Medical Center, New York, New York, USA. 10. Division of Gastroenterology & Hepatology, Columbia University, New York, New York, USA. 11. Division of Gastroenterology & Hepatology, University of Florida, Gainesville, Florida, USA. 12. Division of Gastroenterology & Hepatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. 13. Division of Gastroenterology & Hepatology, Virginia Mason Medical Center, Seattle, Washington, USA. 14. Asian Institute of Gastroenterology, Hyderabad, India.
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.
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.
Authors: Clara Benedetta Conti; Roberto Frego; Alessandro Ettore Redaelli; Marta Maino; Giacomo Mulinacci; Marco Emilio Dinelli Journal: Endosc Int Open Date: 2021-12-14