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
  Purpose

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).


Condition Intervention
Training
Device: ERCP mechanical simulator practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by East Bay Institute for Research and Education:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Trainer assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjective competency (5-point score) graded by supervising physicians.


Enrollment: 16
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ERCP mechanical simulator practice
Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group)
Device: ERCP mechanical simulator practice
Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training
No Intervention: No ERCP mechanical simulator practice
Trainees 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.
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gastrointestinal fellows receiving ERCP training

Exclusion Criteria:

  • Gastrointestinal fellows who are not receiving ERCP training
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080833

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
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
Investigators
Principal Investigator: Joseph W Leung, MD Sacramento VA Medical Center
  More Information

Publications:
Responsible Party: Joseph Leung, MD, EBIRE
ClinicalTrials.gov Identifier: NCT01080833     History of Changes
Other Study ID Numbers: EBIRE-GI-004
Study First Received: March 1, 2010
Last Updated: March 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by East Bay Institute for Research and Education:
EMS
ERCP
Training
Trainees

ClinicalTrials.gov processed this record on September 16, 2014