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Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training

This study has been completed.
Sponsor:
Collaborators:
University of California, Davis
University of California, Irvine
University of Arizona
Phoenix VA Medical Center
University of New Mexico
United States Naval Medical Center, San Diego
Kaiser Permanente
Information provided by:
East Bay Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT01080833
First received: March 1, 2010
Last updated: March 18, 2010
Last verified: March 2010
History of Changes

March 1, 2010
March 18, 2010
July 2008
June 2009   (final data collection date for primary outcome measure)
Diagnostic biliary cannulation and deep biliary cannulation success rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation
Same as current
Complete list of historical versions of study NCT01080833 on ClinicalTrials.gov Archive Site
Trainer assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Subjective competency (5-point score) graded by supervising physicians.
Same as current
Not Provided
Not Provided
 
Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training
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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Training
Device: ERCP mechanical simulator practice
Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training
  • Active Comparator: ERCP mechanical simulator practice
    Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group)
    Intervention: Device: ERCP mechanical simulator practice
  • No Intervention: No ERCP mechanical simulator practice
    Trainees undergoing routine ERCP training only (control group).
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gastrointestinal fellows receiving ERCP training

Exclusion Criteria:

  • Gastrointestinal fellows who are not receiving ERCP training
Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01080833
EBIRE-GI-004
Yes
Joseph Leung, MD, EBIRE
East Bay Institute for Research and Education
  • University of California, Davis
  • University of California, Irvine
  • University of Arizona
  • Phoenix VA Medical Center
  • University of New Mexico
  • United States Naval Medical Center, San Diego
  • Kaiser Permanente
Principal Investigator: Joseph W Leung, MD Sacramento VA Medical Center
East Bay Institute for Research and Education
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP