Hands-on Training
Conditions
Keywords
ERCP, EMS, Cannulation, Successful rate, Trainee
Brief summary
To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.
Detailed description
Practicing Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using the EMS provides opportunities for novice endoscopists to learn basic ERCP skills without a patient. In two randomized controlled trials (RCT), coached EMS practice increased selective bile duct cannulation success rate of novice endoscopists. Surgical trainees do not have sufficient endoscopy experience to meet the perceived basic requirement for ERCP training. However, ERCP is done with a side-viewing scope and even experienced GI trainees have difficult initially mastering the basic skill with scope manipulation and cannulation. It is not known whether EMS can provide additional benefit to novice surgical ERCP trainees.
Interventions
DEVICEERCP Mechanical Simulator (EMS)
Hands on EMS training
Sponsors
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
26 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* No experienced surgical trainees receiving ERCP training
Exclusion criteria
* Experienced surgical ERCP trainees or who are not receiving ERCP training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of bile duct cannulation | 12 months | Trainees received verbal instructions, hands-on assistance from the trainer no more than three times in performing the clinical procedure. The trainer took over if the trainee still failed after 20 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful cannulation time from first achieve the papilla | 12 months | the time between the first achieve the papilla to cannulate successfully |
| Total time | 12 months | From scope explored to withdraw |
| Intubation time before cannulation | 12 months | during the scope explored to cannulation |
| Complication rate | 12 months | The rate of major complications |
| Trainer assessment | 12 months | Subjective competency graded by supervising physicians as above average, average or below average based on objective criteria. |
| performance score of selective cannulation | 12 months | The ability of trainees to perform solo diagnostic biliary cannulation and deep cannulation |
Countries
China
Outcome results
None listed