The Development and Evaluation of a Novel Duodenoscope Assessment Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AdventHealth
- Enrollment
- 745
- Locations
- 9
- Primary Endpoint
- Evaluation of the newly developed duodenoscope assessment tool
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Evaluation of the newly developed duodenoscope assessment tool
Time Frame: 6 months
Assessment of the internal reliability of the duodenoscope assessment tool will be performed, as determined by the Cronbach's coefficient alpha
Secondary Outcomes
- Evaluation of the technical performance of duodenoscopes for performing ERCPs.(1 day)
- Assessment of procedural indications for ERCPs(1 day)
- Assessment of cannulation success for ERCPs(1 day)
- Assessment of adverse event rates during ERCPs(1 month)