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OpenTrials
Completed

NCT Number: NCT00854191

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

In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP training.

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Key information

Conditions

Patients Undergoing ERCP Examination

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • GI trainees who met the minimum endoscopy training experience

Exclusion criteria

  • GI trainees with no endoscopy experience

Treatment and study plan

simulator training

Device

4 half-day of simulator ERCP practice as endoscopist and/or assistant followed by usual training

Primary outcomes

  1. Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation

    Time frame: 3 months

Secondary outcomes

  1. Trainer blinded to the randomization provided assessment of each trainee performed ERCP

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 3, 2009
Registry last updated
Mar 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.