Effect of Simulator Practice on Trainees' Endoscopic Retrograde Cholangiopancreatography (ERCP) Performance in the Early Learning Period

March 2, 2009 updated by: National Taiwan University Hospital

A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance

In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The impact of mechanical simulator practice on clinical ERCP performance has not been reported.

Hypothesis: Practice with mechanical simulator improves clinical ERCP performance of novice trainees.

Design: A prospective randomized controlled trial.

Method: 8 trainees without prior ERCP experience from 2 hospitals attended didactic lectures on ERCP. They were randomized in pairs (per hospital) to receive simulator practice and usual training (S) versus usual training only as control (C). Simulator practice included selective bile and pancreatic duct cannulation using a catheter and/or guide wire with different artificial papillae (flat, standard, dual channels) and settings (standard, rotated papilla or duodenum), and exchange of guide wire/accessories and biliary stenting. Local trainers tracked trainees' subsequent clinical ERCP performance for 3 months. Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation. Trainer blinded to the randomization provided assessment (1=poor, 5=excellent) of each trainee performed ERCP.

Statistics: Fisher exact test and Mann-Whitney U test.

Study Type

Interventional

Enrollment (Actual)

8

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
        • Department of Gastroenterology, National Taiwan University Hospital

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

  • Child
  • 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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
4 half-day of simulator ERCP practice and usual training
Device: simulator training
4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training
Active Comparator: 2
Usual training
Device: simulator training
4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Trainer blinded to the randomization provided assessment of each trainee performed ERCP
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

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

July 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 1, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 3, 2009

Last Update Submitted That Met QC Criteria

March 2, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 200804030R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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