NCT00854191

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
Last Updated

March 3, 2009

Status Verified

March 1, 2009

Enrollment Period

1.6 years

First QC Date

March 1, 2009

Last Update Submit

March 2, 2009

Conditions

Patients Undergoing ERCP Examination

Keywords

mechanical simulatorERCPtraining

Outcome Measures

Primary Outcomes (1)

  • Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation

    3 months

Secondary Outcomes (1)

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

    3 months

Study Arms (2)

1

EXPERIMENTAL

4 half-day of simulator ERCP practice and usual training

Device: simulator training

2

ACTIVE COMPARATOR

Usual training

Device: simulator training

Interventions

simulator trainingDEVICE

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

12

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • GI trainees who met the minimum endoscopy training experience

You may not qualify if:

  • GI trainees with no endoscopy experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Liao WC, Leung JW, Wang HP, Chang WH, Chu CH, Lin JT, Wilson RE, Lim BS, Leung FW. Coached practice using ERCP mechanical simulator improves trainees' ERCP performance: a randomized controlled trial. Endoscopy. 2013 Oct;45(10):799-805. doi: 10.1055/s-0033-1344224. Epub 2013 Jul 29.

    PMID: 23897401DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2009

First Posted

March 3, 2009

Study Start

July 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 3, 2009

Record last verified: 2009-03

Locations

TW(1)