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

March 18, 2010 updated by: East Bay Institute for Research and Education

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gastrointestinal fellows receiving ERCP training

Exclusion Criteria:

  • Gastrointestinal fellows who are not receiving ERCP training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trainer assessment
Time Frame: 12 months
Subjective competency (5-point score) graded by supervising physicians.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Bay Institute for Research and Education

Collaborators

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

Investigators

  • Principal Investigator: Joseph W Leung, MD, Sacramento VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (ESTIMATE)

March 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 18, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EBIRE-GI-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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