Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training
NCT ID: NCT01080833
Last Updated: 2010-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2008-07-31
2009-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ERCP mechanical simulator practice
Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group)
ERCP mechanical simulator practice
Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training
No ERCP mechanical simulator practice
Trainees undergoing routine ERCP training only (control group).
No interventions assigned to this group
Interventions
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ERCP mechanical simulator practice
Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
ALL
Yes
Sponsors
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University of California, Davis
OTHER
University of California, Irvine
OTHER
University of Arizona
OTHER
Phoenix VA Health Care System
FED
University of New Mexico
OTHER
United States Naval Medical Center, San Diego
FED
Kaiser Permanente
OTHER
East Bay Institute for Research and Education
OTHER
Responsible Party
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EBIRE
Principal Investigators
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Joseph W Leung, MD
Role: PRINCIPAL_INVESTIGATOR
Sacramento VA Medical Center
Locations
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UC Davis Medical Center
Sacramento, California, United States
Countries
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References
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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.
Other Identifiers
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EBIRE-GI-004
Identifier Type: -
Identifier Source: org_study_id
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