Effect of Simulator Practice on Trainees' Endoscopic Retrograde Cholangiopancreatography (ERCP) Performance in the Early Learning Period
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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 |
- Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- GI trainees who met the minimum endoscopy training experience
Exclusion Criteria:
- GI trainees with no endoscopy experience
Contacts and Locations More Information
No publications provided
| 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 June 17, 2013