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

• Sponsor: East Bay Institute for Research and Education (Other)
• Overall Status: Completed
• CT.gov ID: NCT01080833
• Collaborator: University of California, Davis (Other), University of California, Irvine (Other), University of Arizona (Other), Phoenix VA Health Care System (U.S. Fed), University of New Mexico (Other), United States Naval Medical Center, San Diego (U.S. Fed), Kaiser Permanente (Other)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Training	Device: ERCP mechanical simulator practice	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ERCP mechanical simulator practice Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group)	Device: ERCP mechanical simulator practice; Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training
No Intervention: No ERCP mechanical simulator practice Trainees undergoing routine ERCP training only (control group).

Outcome Measures

Primary Outcome Measures

1. Diagnostic biliary cannulation and deep biliary cannulation success rates [12 months]

   The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation

Secondary Outcome Measures

1. Trainer assessment [12 months]

   Subjective competency (5-point score) graded by supervising physicians.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Gastrointestinal fellows receiving ERCP training

Exclusion Criteria:

• Gastrointestinal fellows who are not receiving ERCP training

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Medical Center	Sacramento	California	United States	95817

Sponsors and Collaborators

• East Bay Institute for Research and Education
• University of California, Davis
• University of California, Irvine
• University of Arizona
• Phoenix VA Health Care System
• University of New Mexico
• United States Naval Medical Center, San Diego
• Kaiser Permanente

Investigators

• Principal Investigator: Joseph W Leung, MD, Sacramento VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT01080833
• Other Study ID Numbers: EBIRE-GI-004
• First Posted: Mar 4, 2010
• Last Update Posted: Mar 19, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: EMS; ERCP; Training; Trainees

Study Results

No Results Posted as of Mar 19, 2010