Completed

NCT Number: NCT04004533

The Development and Evaluation of a Novel Duodenoscope Assessment Tool

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.

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Key information

Conditions

Dudoenoscope Assessment Tool

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas, Little Rock, Arkansas, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 18 years or older
Undergoing ERCP using a duodenoscope

Exclusion criteria

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

Treatment and study plan

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Procedure

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 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.

Time frame: 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

Time frame: 1 day

The procedural indications for performing ERCPs will be assessed
Assessment of cannulation success for ERCPs

Time frame: 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

Time frame: 1 month

The rate of adverse events during an ERCP will be assessed

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jul 2, 2019
Registry last updated: Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.