NCT02838498

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2018

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

July 17, 2016

Last Update Submit

July 9, 2019

Conditions

Hands-on Training

Keywords

ERCPEMSCannulationSuccessful rateTrainee

Outcome Measures

Primary Outcomes (1)

  • Success rate of bile duct cannulation

    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 Outcomes (6)

  • Intubation time before cannulation

    12 months

  • Successful cannulation time from first achieve the papilla

    12 months

  • Total time

    12 months

  • performance score of selective cannulation

    12 months

  • Complication rate

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Intensive EMS training group

EXPERIMENTAL

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)

Routine ERCP training group

NO INTERVENTION

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.

Interventions

ERCP Mechanical Simulator (EMS)DEVICE

Hands on EMS training

Intensive EMS training group

Eligibility Criteria

Age26 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No experienced surgical trainees receiving ERCP training

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (2)

  • Liao WC, Leung JW, Wang HP, Chang WH, Chu CH, Lin JT, Wilson RE, Lim BS, Leung FW. Coached practice using ERCP mechanical simulator improves trainees' ERCP performance: a randomized controlled trial. Endoscopy. 2013 Oct;45(10):799-805. doi: 10.1055/s-0033-1344224. Epub 2013 Jul 29.

    PMID: 23897401RESULT

  • Lim BS, Leung JW, Lee J, Yen D, Beckett L, Tancredi D, Leung FW. Effect of ERCP mechanical simulator (EMS) practice on trainees' ERCP performance in the early learning period: US multicenter randomized controlled trial. Am J Gastroenterol. 2011 Feb;106(2):300-6. doi: 10.1038/ajg.2010.411. Epub 2010 Oct 26.

    PMID: 20978485RESULT

Study Officials

  • Xun Li, M.D., Ph. D.

    Hepatopancreatobiliary Surgery Institute of Gansu Province

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2016

First Posted

July 20, 2016

Study Start

July 1, 2016

Primary Completion

December 26, 2018

Study Completion

December 26, 2018

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)