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

Not Applicable

Completed

• Conditions: Patients Undergoing ERCP Examination
• Interventions: Device: simulator training

• Registration Number: NCT00854191
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Study Start: 2007-07
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-03
• Study First Submitted: 2009-03-01
• Study First Submitted QC: 2009-03-02
• Last Update Submitted: 2009-03-02
• Study First Posted: 2009-03-03
• Last Update Posted: 2009-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• GI trainees who met the minimum endoscopy training experience

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Exclusion Criteria

• GI trainees with no endoscopy experience

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	simulator training	4 half-day of simulator ERCP practice and usual training
2	simulator training	Usual training

Primary Outcome Measures

Name	Time	Method
Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation	3 months

Secondary Outcome Measures

Name	Time	Method
Trainer blinded to the randomization provided assessment of each trainee performed ERCP	3 months

Trial Locations

Locations (1)

Department of Gastroenterology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan