Practice With Simulator Improves Basic ERCP Skills of Surgical Trainees

Not Applicable

Completed

• Conditions: Hands-on Training
• Interventions: Device: ERCP Mechanical Simulator (EMS)

• Registration Number: NCT02838498
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-17
• Study First Submitted QC: 2016-07-17
• Study First Posted: 2016-07-20
• Primary Completion: 2018-12-26
• Study Completion: 2018-12-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• No experienced surgical trainees receiving ERCP training

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive EMS training group	ERCP Mechanical Simulator (EMS)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Total time	12 months	From scope explored to withdraw
Complication rate	12 months	The rate of major complications
Intubation time before cannulation	12 months	during the scope explored to cannulation
Successful cannulation time from first achieve the papilla	12 months	the time between the first achieve the papilla to cannulate successfully
performance score of selective cannulation	12 months	The ability of trainees to perform solo diagnostic biliary cannulation and deep cannulation
Trainer assessment	12 months	Subjective competency graded by supervising physicians as above average, average or below average based on objective criteria.

Trial Locations

Locations (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province; 🇨🇳 Lanzhou, Gansu, China