Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training

Training Clinical Trial

— ERCP  

Official title:

Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080833
• Other study ID #: EBIRE-GI-004
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: March 18, 2010
• Start date: July 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: East Bay Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).

Description:

Hypothesis #1: Trainees who are offered simulator training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).

Hypothesis #2: Trainees who are initially in the control arm, but receive the simulator training after the initial 30 procedures (delayed intervention) will have significantly greater improvement of clinical outcomes in the second phase of the study (steeper learning curve) compared to the initial period.

STUDY DESIGN & OUTCOMES

• Controlled randomized observational study.

• Immediate intervention (simulator training in the beginning of or just prior to the trainees' ERCP rotation) and delayed intervention (simulator training after 30 clinical procedures) will be studied

• Primary outcome: diagnostic biliary cannulation and deep biliary cannulation success rates Secondary outcomes: cannulation time, subjective competency score (5-point scale) graded by supervising physicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Gastrointestinal fellows receiving ERCP training

Exclusion Criteria:

• Gastrointestinal fellows who are not receiving ERCP training

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Training

Intervention

Device:
• ERCP mechanical simulator practice
Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (8)

Lead Sponsor	Collaborator
East Bay Institute for Research and Education	Kaiser Permanente, Phoenix VA Medical Center, United States Naval Medical Center, San Diego, University of Arizona, University of California, Davis, University of California, Irvine, University of New Mexico

Country where clinical trial is conducted

United States, 

References & Publications (1)

Leung JW, Lee JG, Rojany M, Wilson R, Leung FW. Development of a novel ERCP mechanical simulator. Gastrointest Endosc. 2007 Jun;65(7):1056-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic biliary cannulation and deep biliary cannulation success rates	The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation	12 months	No
Secondary	Trainer assessment	Subjective competency (5-point score) graded by supervising physicians.	12 months	No