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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 1, 2009
Last Updated Date	March 2, 2009
Start Date ^ICMJE	July 2007
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2009)	Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00854191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2009)	Trainer blinded to the randomization provided assessment of each trainee performed ERCP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Simulator Practice on Trainees' Endoscopic Retrograde Cholangiopancreatography (ERCP) Performance in the Early Learning Period
Official Title ^ICMJE	A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance
Brief Summary	In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP 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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research
Condition ^ICMJE	Patients Undergoing ERCP Examination
Intervention ^ICMJE	Device: simulator training 4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training
Study Arm (s)	Experimental: 1 4 half-day of simulator ERCP practice and usual training Intervention: Device: simulator training Active Comparator: 2 Usual training Intervention: Device: simulator training
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	8
Completion Date	February 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: GI trainees who met the minimum endoscopy training experience Exclusion Criteria: GI trainees with no endoscopy experience
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT Number ^ICMJE	NCT00854191
Other Study ID Numbers ^ICMJE	200804030R
Has Data Monitoring Committee	Yes
Responsible Party	Joseph Leung, East Bay Institute for Research and Education
Study Sponsor ^ICMJE	National Taiwan University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Taiwan University Hospital
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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