TrainingERCPNCT01080833
Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training
A study testing ERCP mechanical simulator practice in people with Training, run by East Bay Institute for Research and Education at 1 site in United States.
Trial summary
Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group). Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Training
- What is being tested?
- ERCP mechanical simulator practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2009
- Phase
- Interventional
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gastrointestinal fellows receiving ERCP training
Who cannot join
- Gastrointestinal fellows who are not receiving ERCP training
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study
Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).
Read the detailed description
Hypothesis #1: Trainees who are offered simulator training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).
Hypothesis #2: Trainees who are initially in the control arm, but receive the simulator training after the initial 30 procedures (delayed intervention) will have significantly greater improvement of clinical outcomes in the second phase of the study (steeper learning curve) compared to the initial period.
STUDY DESIGN \& OUTCOMES
- Controlled randomized observational study.
- Immediate intervention (simulator training in the beginning of or just prior to the trainees' ERCP rotation) and delayed intervention (simulator training after 30 clinical procedures) will be studied
- Primary outcome: diagnostic biliary cannulation and deep biliary cannulation success rates Secondary outcomes: cannulation time, subjective competency score (5-point scale) graded by supervising physicians.
- Conditions
- Training
- Being tested
- ERCP mechanical simulator practice
- Keywords
- EMS, ERCP, Training, Trainees
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP mechanical simulator practiceDevice
Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training
| Study group | Role | What they receive |
|---|---|---|
| ERCP mechanical simulator practice | Active comparator | Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) Receives: Device: ERCP mechanical simulator practice |
| No ERCP mechanical simulator practice | No intervention | Trainees undergoing routine ERCP training only (control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic biliary cannulation and deep biliary cannulation success rates
The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation
Measured: 12 months
Secondary outcomes (1)
Trainer assessment
Subjective competency (5-point score) graded by supervising physicians.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionDec 2009
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 TrainingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Bay Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, University of California, Irvine, University of Arizona, Phoenix VA Health Care System, University of New Mexico, United States Naval Medical Center, San Diego, Kaiser Permanente
- Investigators
- Joseph W Leung, MD, Principal investigator, Sacramento VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080833
- Sponsor's protocol ID
- EBIRE-GI-004
- Acronym
- ERCP
- Status last verified
- Mar 2010
- First submitted
- 1 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leung JW, Lee JG, Rojany M, Wilson R, Leung FW. Development of a novel ERCP mechanical simulator. Gastrointest Endosc. 2007 Jun;65(7):1056-62. doi: 10.1016/j.gie.2006.11.018.
PubMed 17531642
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study
- ClinicalTrials.gov ID
- NCT01080833
- Acronym / sponsor ID
- ERCP / EBIRE-GI-004
- Conditions
- Training
- Keywords
- EMS, ERCP, Training, Trainees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- East Bay Institute for Research and EducationUniversity, hospital or other
- Collaborators
- University of California, Davis, University of California, Irvine, University of Arizona, Phoenix VA Health Care System, University of New Mexico, United States Naval Medical Center, San Diego, Kaiser Permanente
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Mar 2010 (estimated)
- 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.
Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).
Detailed description
Hypothesis #1: Trainees who are offered simulator training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).
Hypothesis #2: Trainees who are initially in the control arm, but receive the simulator training after the initial 30 procedures (delayed intervention) will have significantly greater improvement of clinical outcomes in the second phase of the study (steeper learning curve) compared to the initial period.
STUDY DESIGN \& OUTCOMES
- Controlled randomized observational study.
- Immediate intervention (simulator training in the beginning of or just prior to the trainees' ERCP rotation) and delayed intervention (simulator training after 30 clinical procedures) will be studied
- Primary outcome: diagnostic biliary cannulation and deep biliary cannulation success rates Secondary outcomes: cannulation time, subjective competency score (5-point scale) graded by supervising physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP mechanical simulator practice | Active comparator | Device: ERCP mechanical simulator practiceTrainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) |
| No ERCP mechanical simulator practice | No intervention | –Trainees undergoing routine ERCP training only (control group). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gastrointestinal fellows receiving ERCP training
Key exclusion criteria (1 listed)
- Gastrointestinal fellows who are not receiving ERCP training
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 |
|---|---|---|
| ERCP mechanical simulator practiceTrainees will receive ERCP mechanical simulator practice in addition to routine ERCP training | Device | ERCP mechanical simulator practice |
Primary outcome
Diagnostic biliary cannulation and deep biliary cannulation success rates
Time frame: 12 months
The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation
1 secondary outcome
Trainer assessment
Time frame: 12 months
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 19 Mar 2010.
- Background: PubMed 17531642Leung JW, Lee JG, Rojany M, Wilson R, Leung FW. Development of a novel ERCP mechanical simulator. Gastrointest Endosc. 2007 Jun;65(7):1056-62. doi: 10.1016/j.gie.2006.11.018.
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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.
Joseph W Leung, MD principal investigator
Sacramento VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP mechanical simulator practice in people with Training, run by East Bay Institute for Research and Education at 1 site 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 1 inclusion and 1 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 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Diagnostic biliary cannulation and deep biliary cannulation success rates (time frame: 12 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 NCT01080833, 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 19 Mar 2010.