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

E

East Bay Institute for Research and Education

Status

Completed

Conditions

Training

Treatments

Device: ERCP mechanical simulator practice

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01080833
EBIRE-GI-004

Details and patient eligibility

About

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).

Full 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.

Enrollment

16 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Gastrointestinal fellows receiving ERCP training

Exclusion criteria

  • Gastrointestinal fellows who are not receiving ERCP training

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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