Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 2:07 PM
Study NCT ID:
NCT01080833
Status:
COMPLETED
Last Update Posted:
2010-03-19
First Post:
2010-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training
Sponsor:
East Bay Institute for Research and Education
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERCP
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).
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: