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.

Study Overview

• Status: Completed
• Conditions: Dudoenoscope Assessment Tool
• Intervention / Treatment: Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)

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 Type: Observational
• Enrollment (Actual): 745

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Orlando, Florida, United States, 32803
      • Center for Interventional Endoscopy
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the technical performance of duodenoscopes for performing ERCPs.	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).	1 day
Assessment of procedural indications for ERCPs	The procedural indications for performing ERCPs will be assessed	1 day
Assessment of cannulation success for ERCPs	The number of attempts for successful cannulation of the desired duct during an ERCP will be assessed	1 day
Assessment of adverse event rates during ERCPs	The rate of adverse events during an ERCP will be assessed	1 month

Collaborators and Investigators

• Sponsor: AdventHealth

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: duodenoscope; Endoscopic retrograded cholangiopancreatography; duodenoscope assessment tool
• Other Study ID Numbers: 1434658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No