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

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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01080833

Acronym

ERCP

Enrollment

Registered

2010-03-04

Start date

2008-07-31

Completion date

2009-12-31

Last updated

2010-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Training

Keywords

EMS, ERCP, Training, Trainees

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.

Interventions

DEVICEERCP mechanical simulator practice

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Gastrointestinal fellows receiving ERCP training

Exclusion criteria

* Gastrointestinal fellows who are not receiving ERCP training

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Trainer assessment	12 months	Subjective competency (5-point score) graded by supervising physicians.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026