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

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National Taiwan University

Status

Completed

Conditions

Patients Undergoing ERCP Examination

Treatments

Device: simulator training

Study type

Interventional

Funder types

Other

Identifiers

NCT00854191
200804030R

Details and patient eligibility

About

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

Full 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.

Enrollment

8 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • GI trainees who met the minimum endoscopy training experience

Exclusion criteria

  • GI trainees with no endoscopy experience

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

8 participants in 2 patient groups

1
Experimental group
Description:
4 half-day of simulator ERCP practice and usual training
Treatment:
Device: simulator training
2
Active Comparator group
Description:
Usual training
Treatment:
Device: simulator training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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