Clinical trial NCT04004533: The Development and Evaluation of a Novel Duodenoscope Assessment Tool
Official title: The Development and Evaluation of a Novel Duodenoscope Assessment Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dudoenoscope Assessment Tool
Keywords: duodenoscope
Endoscopic retrograded cholangiopancreatography
duodenoscope assessment tool
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 745
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: Inclusion Criteria

1. Aged 18 years or older
2. Undergoing ERCP using a duodenoscope

Exclusion Criteria

1. Aged less than 18 years old
2. Not undergoing ERCP using a duodenoscope

Primary outcomes:
measure: Evaluation of the newly developed duodenoscope assessment tool
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the technical performance of duodenoscopes for performing ERCPs.
timeFrame: 1 day
measure: Assessment of procedural indications for ERCPs
timeFrame: 1 day
measure: Assessment of cannulation success for ERCPs
timeFrame: 1 day
measure: Assessment of adverse event rates during ERCPs
timeFrame: 1 month
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: Center for Interventional Endoscopy
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Pittsburgh
country: United States
facility: Allegheny Health
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: AdventHealth Orlando
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.