The Development and Evaluation of a Novel Duodenoscope Assessment Tool
NCT ID: NCT04004533
Last Updated: 2022-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
745 participants
OBSERVATIONAL
2019-05-20
2021-12-31
Brief Summary
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The Center for Interventional Endoscopy has maintained a multicenter database that prospectively evaluates the technical performance of duodenoscopes for performing ERCPs. Our objective is to analyze the database in order to summarize the technical performance of duodenoscopes during ERCPs and evaluate the reliability of the duodenoscope assessment tool.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Endoscopic retrograde cholangiopancreatography (ERCP)
At the time of each ERCP procedure, information on procedure indication, technical performance of the duodenoscope and adverse events will be collected using a newly designed duodenoscope assessment tool. The duodenoscope assessment tool was developed to measure the technical performance of the duodenoscopes based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component is graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability). Duodenoscope assessment tool also captures data on procedural indications, cannulation success rates and adverse events.
Endoscopic retrograde cholangiopancreatography (ERCP)
At the time of each ERCP procedure, information on procedure indication, technical performance of the duodenoscope and adverse events will be collected using a newly designed duodenoscope assessment tool. The duodenoscope assessment tool was developed to measure the technical performance of the duodenoscopes based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component is graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability). Duodenoscope assessment tool also captures data on procedural indications, cannulation success rates and adverse events.
Interventions
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Endoscopic retrograde cholangiopancreatography (ERCP)
At the time of each ERCP procedure, information on procedure indication, technical performance of the duodenoscope and adverse events will be collected using a newly designed duodenoscope assessment tool. The duodenoscope assessment tool was developed to measure the technical performance of the duodenoscopes based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component is graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability). Duodenoscope assessment tool also captures data on procedural indications, cannulation success rates and adverse events.
Eligibility Criteria
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Inclusion Criteria
2. Undergoing ERCP using a duodenoscope
Exclusion Criteria
2. Not undergoing ERCP using a duodenoscope
18 Years
ALL
No
Sponsors
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AdventHealth
OTHER
Responsible Party
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Principal Investigators
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Shyam Varadarajulu, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth Orlando
Locations
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University of Arkansas
Little Rock, Arkansas, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Center for Interventional Endoscopy
Orlando, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University
New York, New York, United States
Allegheny Health
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Countries
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References
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Bang JY, Rosch T, Kim HM, Thakkar S, Robalino Gonzaga E, Tharian B, Inamdar S, Lee LS, Yachimski P, Jamidar P, Muniraj T, DiMaio C, Kumta N, Sethi A, Draganov P, Yang D, Seoud T, Perisetti A, Bondi G, Kirtane S, Hawes R, Wilcox CM, Kozarek R, Reddy DN, Varadarajulu S. Prospective evaluation of an assessment tool for technical performance of duodenoscopes. Dig Endosc. 2021 Jul;33(5):822-828. doi: 10.1111/den.13856. Epub 2020 Nov 17.
Other Identifiers
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1434658
Identifier Type: -
Identifier Source: org_study_id
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