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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:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00854191
First received: March 1, 2009
Last updated: March 2, 2009
Last verified: March 2009
  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 Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trainer blinded to the randomization provided assessment of each trainee performed ERCP [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00854191

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

No publications provided by National Taiwan University Hospital

Additional 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
Study First Received: March 1, 2009
Last Updated: March 2, 2009
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on November 27, 2014