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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00854191
Enrollment
8
Registered
2009-03-03
Start date
2007-07-31
Completion date
2009-02-28
Last updated
2009-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing ERCP Examination

Keywords

mechanical simulator, ERCP, training

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.

Interventions

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* GI trainees who met the minimum endoscopy training experience

Exclusion criteria

* GI trainees with no endoscopy experience

Design outcomes

Primary

MeasureTime frame
Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation3 months

Secondary

MeasureTime frame
Trainer blinded to the randomization provided assessment of each trainee performed ERCP3 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026