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Practice With Simulator Improves Basic ERCP Skills of Surgical Trainees

H

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status

Completed

Conditions

Hands-on Training

Treatments

Device: ERCP Mechanical Simulator (EMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT02838498
Surgical ERCP EMS training

Details and patient eligibility

About

To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.

Full 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.

Enrollment

12 patients

Sex

All

Ages

26+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • No experienced surgical trainees receiving ERCP training

Exclusion criteria

  • Experienced surgical ERCP trainees or who are not receiving ERCP training

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

12 participants in 2 patient groups

Intensive EMS training group
Experimental group
Description:
Device: ERCP mechanical simulator training EMS group was coached (by JWL) on how to use the EMS, and then practiced with supervision by a senior surgeon biliary endoscopist (WBM). Trainees practiced for a total of 20 hours performing basic maneuvers including scope insertion 2 hours, scope positioning 6 hours, selective guide wire cannulation of common bile duct (CBD) stricture or pancreatic duct (PD) 10 hours and placement of a biliary stent 2 hours. All trainees received hands-on supervised clinical ERCP practice on patients. Time taken to perform ERCP procedures was documented. Trainees received verbal instructions, hands-on assistance from the trainer in performing the clinical procedure. If the trainee still failed after 20 minutes, the trainer took over.
Treatment:
Device: ERCP Mechanical Simulator (EMS)
Routine ERCP training group
No Intervention group
Description:
Other: Routine ERCP training group All trainees received hands-on supervised clinical ERCP practice on patients. Time taken to perform ERCP procedures was documented. Trainees received verbal instructions, hands-on assistance from the trainer in performing the clinical procedure. If the trainee still failed after 20 minutes, the trainer took over.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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