Dudoenoscope Assessment ToolNCT04004533
The Development and Evaluation of a Novel Duodenoscope Assessment Tool
An observational study of Dudoenoscope Assessment Tool, run by AdventHealth at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dudoenoscope Assessment Tool
- What is being tested?
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 745 participants
- Where
- 9 sitesUnited States
- Study dates
- 20 May 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Aged 18 years or older
- Undergoing ERCP using a duodenoscope
Who cannot join
- Aged less than 18 years old
- Not undergoing ERCP using a duodenoscope
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Florida
Gainesville, Florida, 32610
University of Arkansas
Little Rock, Arkansas, 72205
Vanderbilt University
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06520
Mount Sinai Hospital
New York, New York, 10029
Columbia University
New York, New York, 10032
Center for Interventional Endoscopy
Orlando, Florida, 32803
Allegheny Health
Pittsburgh, Pennsylvania, 15212
About this study
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.
Read the 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.
- Conditions
- Dudoenoscope Assessment Tool
- Being tested
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Keywords
- duodenoscope, Endoscopic retrograded cholangiopancreatography, duodenoscope assessment tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancreatography (ERCP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endoscopic retrograde cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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).
Measured: 1 day
Assessment of procedural indications for ERCPs
The procedural indications for performing ERCPs will be assessed
Measured: 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
Measured: 1 day
Assessment of adverse event rates during ERCPs
The rate of adverse events during an ERCP will be assessed
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start20 May 2019
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dudoenoscope Assessment ToolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 745 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth Orlando
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004533
- Sponsor's protocol ID
- 1434658
- Status last verified
- Feb 2022
- First submitted
- 5 Jun 2019
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
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.
PubMed 33007136
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of a Novel Duodenoscope Assessment Tool
- ClinicalTrials.gov ID
- NCT04004533
- Acronym / sponsor ID
- 1434658
- Conditions
- Dudoenoscope Assessment Tool
- Keywords
- duodenoscope, Endoscopic retrograded cholangiopancreatography, duodenoscope assessment tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 745 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic retrograde cholangiopancreatography (ERCP) | – | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Aged 18 years or older
- Undergoing ERCP using a duodenoscope
Key exclusion criteria (2 listed)
- Aged less than 18 years old
- Not undergoing ERCP using a duodenoscope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Endoscopic retrograde cholangiopancreatography (ERCP) |
Primary outcome
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
4 secondary outcomes
Evaluation of the technical performance of duodenoscopes for performing ERCPs.
Time frame: 1 day
Assessment of procedural indications for ERCPs
Time frame: 1 day
Assessment of cannulation success for ERCPs
Time frame: 1 day
Assessment of adverse event rates during ERCPs
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Derived from this study: PubMed 33007136Bang 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyam Varadarajulu, MD principal investigator
AdventHealth Orlando
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dudoenoscope Assessment Tool, run by AdventHealth at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the newly developed duodenoscope assessment tool (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.