Practice With Simulator Improves Basic ERCP Skills of Surgical Trainees

July 9, 2019 updated by: Hepatopancreatobiliary Surgery Institute of Gansu Province

Practice With ERCP Mechanical Simulator (EMS) Improves Basic ERCP Skills of Novice Surgical Trainees

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No experienced surgical trainees receiving ERCP training

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive EMS training group

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.
Device: ERCP Mechanical Simulator (EMS)
Hands on EMS training
No Intervention: Routine ERCP training group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of bile duct cannulation
Time Frame: 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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Investigators

  • Principal Investigator: Xun Li, M.D., Ph. D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 26, 2018

Study Completion (Actual)

December 26, 2018

Study Registration Dates

First Submitted

July 17, 2016

First Submitted That Met QC Criteria

July 17, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 11, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Surgical ERCP EMS training

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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