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Completed

NCT Number: NCT02838498

Practice With Simulator Improves Basic ERCP Skills of Surgical Trainees

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

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Key information

Conditions

Hands-on Training

Age range

26 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No experienced surgical trainees receiving ERCP training

Exclusion criteria

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

Treatment and study plan

ERCP Mechanical Simulator (EMS)

Device

Hands on EMS training

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intubation time before cannulation

    Time frame: 12 months

    during the scope explored to cannulation

  2. Successful cannulation time from first achieve the papilla

    Time frame: 12 months

    the time between the first achieve the papilla to cannulate successfully

  3. Total time

    Time frame: 12 months

    From scope explored to withdraw

  4. performance score of selective cannulation

    Time frame: 12 months

    The ability of trainees to perform solo diagnostic biliary cannulation and deep cannulation

  5. Complication rate

    Time frame: 12 months

    The rate of major complications

  6. Trainer assessment

    Time frame: 12 months

    Subjective competency graded by supervising physicians as above average, average or below average based on objective criteria.

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2016
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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