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CompletedNCT01080833ERCPUpdated Mar 19, 2010

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

An interventional study of ERCP mechanical simulator practice in Training, sponsored by East Bay Institute for Research and Education. Completed at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-19.

Sponsored by East Bay Institute for Research and Education · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • Training

Keywords

  • EMS
  • ERCP
  • Training
  • Trainees
03

In context

Lead sponsor

East Bay Institute for Research and Education is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Gastrointestinal fellows receiving ERCP training

Exclusion criteria

Exclusion Criteria:

  • Gastrointestinal fellows who are not receiving ERCP training
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • 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

  • No intervention
    No ERCP mechanical simulator practice

    Trainees undergoing routine ERCP training only (control group).

Interventions

  • DeviceERCP mechanical simulator practice

    Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training

06

What researchers measure

Primary outcomes

  1. Diagnostic biliary cannulation and deep biliary cannulation success rates

    The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation

    Time frame: 12 months

Secondary outcomes

  1. Trainer assessment

    Subjective competency (5-point score) graded by supervising physicians.

    Time frame: 12 months

07

Study locations

1 site
  • UC Davis Medical Center
    Sacramento, California 95817, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01080833
Lead sponsor
East Bay Institute for Research and Education
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
First posted
Mar 4, 2010
Start date
Jul 2008
Primary completion
Jun 2009
Completion
Dec 2009
Last update
Mar 19, 2010

Study contacts

Joseph W Leung, MD
principal investigator · Sacramento VA Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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