NCT02393638

Brief Summary

This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

February 10, 2015

Last Update Submit

March 18, 2015

Conditions

Endoscopic Sphincterotomy

Keywords

Endoscopic Sphincterotomy

Outcome Measures

Primary Outcomes (1)

  • proportion of endoscopic sphincterotomy successfully performed by trainees

    1year

Secondary Outcomes (1)

  • Improvement in overall performance as measured by sphincterotomy score

    1 year

Study Arms (2)

study group

EXPERIMENTAL

Simulation and lecture

Other: Simulation and lecture

control group

ACTIVE COMPARATOR

Lecture only

Other: Lecture

Interventions

Simulation and lectureOTHER

Endoscopic sphincterotomy on simulator and lecture

study group
LectureOTHER

Lecture

control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

RECRUITING

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: 23897401RESULT

Study Officials

  • W C Liao, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

W C Liao, MD

CONTACT

886-2-23123456david.ntuh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

March 19, 2015

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

TW(1)