The Development and Evaluation of a Novel Duodenoscope Assessment Tool
1 other identifier
observational
745
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2019
CompletedFirst Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 17, 2022
February 1, 2022
2.5 years
June 5, 2019
February 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the newly developed duodenoscope assessment tool
Assessment of the internal reliability of the duodenoscope assessment tool will be performed, as determined by the Cronbach's coefficient alpha
6 months
Secondary Outcomes (4)
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
Study Arms (1)
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
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
Any patient undergoing an ERCP with a duodenoscope and meeting the inclusion criteria will have the technical aspects of the duodenoscope function evaluated using the duodenoscope assessment tool
You may qualify if:
- Aged 18 years or older
- Undergoing ERCP using a duodenoscope
You may not qualify if:
- Aged less than 18 years old
- Not undergoing ERCP using a duodenoscope
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AdventHealthlead
Study Sites (9)
University of Arkansas
Little Rock, Arkansas, 72205, United States
Yale University
New Haven, Connecticut, 06520, United States
University of Florida
Gainesville, Florida, 32610, United States
Center for Interventional Endoscopy
Orlando, Florida, 32803, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Allegheny Health
Pittsburgh, Pennsylvania, 15212, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Related Publications (1)
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.
PMID: 33007136DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shyam Varadarajulu, MD
AdventHealth Orlando
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
July 2, 2019
Study Start
May 20, 2019
Primary Completion
October 31, 2021
Study Completion
December 31, 2021
Last Updated
February 17, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share IPD.