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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00854191
First Posted: March 3, 2009
Last Update Posted: March 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP training.

Condition Intervention
Patients Undergoing ERCP Examination Device: simulator training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Trainer blinded to the randomization provided assessment of each trainee performed ERCP [ Time Frame: 3 months ]

Enrollment: 8
Study Start Date: July 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • GI trainees who met the minimum endoscopy training experience

Exclusion Criteria:

  • GI trainees with no endoscopy experience
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854191


Locations
Taiwan
Department of Gastroenterology, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Leung, East Bay Institute for Research and Education
ClinicalTrials.gov Identifier: NCT00854191     History of Changes
Other Study ID Numbers: 200804030R
First Submitted: March 1, 2009
First Posted: March 3, 2009
Last Update Posted: March 3, 2009
Last Verified: March 2009

Keywords provided by National Taiwan University Hospital:
mechanical simulator
ERCP
training