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OpenTrials
Completed

NCT Number: NCT01080833

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

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).

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Key information

Conditions

Training

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gastrointestinal fellows receiving ERCP training

Exclusion criteria

  • Gastrointestinal fellows who are not receiving ERCP training

Treatment and study plan

ERCP mechanical simulator practice

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Trainer assessment

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

East Bay Institute for Research and Education

Other

Collaborators

  • Kaiser Permanente
  • Phoenix VA Health Care System
  • United States Naval Medical Center, San Diego
  • University of Arizona
  • University of California, Davis
  • University of California, Irvine
  • University of New Mexico

Registry information

Official study title

Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study

Acronym: ERCP

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 4, 2010
Registry last updated
Mar 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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