ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy

Endoscopic Sphincterotomy Clinical Trial

Official title:

ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02393638
• Other study ID #: 201403004RIND
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2015
• Last updated: March 18, 2015
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: National Taiwan University Hospital
• Contact: W C Liao, MD
• Phone: 886-2-23123456
• Email: david.ntuh[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Description:

Usual clinical ERCP training is supervised hands-on practice and the number of procedures is used as a surrogate for trainees' experience. At least 180 cases are required to achieve ERCP competence. A major limitation is lack of suitable patients. Alternative supplemental training includes simulator practice using computer simulators, live animal models, and ex-vivo porcine organ. Our previous study has showed that the mechanical simulator training improves trainees' clinical performance in terms of success of deep CBD cannulation. In this study, we aim to evaluate the usefulness of ERCP mechanical simulator for training endoscopic sphincterotomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• GI trainees who met the minimum endoscopy training experience

Exclusion Criteria:

• GI trainees with no endoscopy experience

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Endoscopic Sphincterotomy

Intervention

Other:
• Simulation and lecture
Endoscopic sphincterotomy on simulator and lecture
• Lecture
Lecture

Locations

Country	Name	City	State
Taiwan	Department of Gastroenterology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of endoscopic sphincterotomy successfully performed by trainees		1year	No
Secondary	Improvement in overall performance as measured by sphincterotomy score		1 year	No