The Development and Evaluation of a Novel Duodenoscope Assessment Tool
- Conditions
- Dudoenoscope Assessment Tool
- Interventions
- Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)
- Registration Number
- NCT04004533
- Lead Sponsor
- AdventHealth
- Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed using duodenoscopes for the treatment of pancreatic and biliary diseases. Although outcomes in endoscopic retrograde cholangiopancreatography (ERCP) procedures are measured mainly in terms of procedural success and complications, currently there are no objective tools to assess the technical performance of the duodenoscopes.
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.
- Detailed Description
Outcomes in ERCP are measured mainly in terms of procedural success and complications. Recently, disposable duodenoscopes have been developed to overcome the challenges associated with reusable duodenoscope-related infections. While it is important to measure the technical performance of the newly developed disposable duodenoscope relative to conventional reusable scopes, presently, there are no objective tools to accomplish this task. The aim of this registry is to assess the reliability of a newly designed assessment tool to evaluate the technical performance of the currently available duodenoscopes. The duodenoscope assessment tool will be completed by each endoscopist after performing the ERCP and this data will be summarized and analyzed to assess the technical performance of the duodenoscopes and also to assess validity of the duodenoscope assessment tool. This is a multicenter study, with data collection from multiple centers across the United States.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 745
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Endoscopic retrograde cholangiopancreatography (ERCP) 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.
- Primary Outcome Measures
Name Time Method Evaluation of the newly developed duodenoscope assessment tool 6 months Assessment of the internal reliability of the duodenoscope assessment tool will be performed, as determined by the Cronbach's coefficient alpha
- Secondary Outcome Measures
Name Time Method Evaluation of the technical performance of duodenoscopes for performing ERCPs. 1 day The technical performance of the duodenoscope during each ERCP will be based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component will be graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability).
Assessment of procedural indications for ERCPs 1 day The procedural indications for performing ERCPs will be assessed
Assessment of cannulation success for ERCPs 1 day The number of attempts for successful cannulation of the desired duct during an ERCP will be assessed
Assessment of adverse event rates during ERCPs 1 month The rate of adverse events during an ERCP will be assessed
Trial Locations
- Locations (9)
Center for Interventional Endoscopy
🇺🇸Orlando, Florida, United States
Columbia University
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Allegheny Health
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States