ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy

March 18, 2015 updated by: National Taiwan University Hospital
This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Usual clinical ERCP training is supervised hands-on practice and the number of procedures is used as a surrogate for trainees' experience. At least 180 cases are required to achieve ERCP competence. A major limitation is lack of suitable patients. Alternative supplemental training includes simulator practice using computer simulators, live animal models, and ex-vivo porcine organ. Our previous study has showed that the mechanical simulator training improves trainees' clinical performance in terms of success of deep CBD cannulation. In this study, we aim to evaluate the usefulness of ERCP mechanical simulator for training endoscopic sphincterotomy.

Study Type

Interventional

Enrollment (Anticipated)

20

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

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Department of Gastroenterology, National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • W C Liao, MD

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GI trainees who met the minimum endoscopy training experience

Exclusion Criteria:

  • GI trainees with no endoscopy experience

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
Simulation and lecture
Other: Simulation and lecture
Endoscopic sphincterotomy on simulator and lecture
Active Comparator: control group
Lecture only
Other: Lecture
Lecture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of endoscopic sphincterotomy successfully performed by trainees
Time Frame: 1year
1year

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in overall performance as measured by sphincterotomy score
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: W C Liao, MD, National Taiwan University Hospital

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

April 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201403004RIND

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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