NCT02022605

Brief Summary

Previous studies have demonstrated that coached EMS practice at the beginning of ERCP training could improve the trainees' skill. However, it is not known whether continuously coached practice using EMS can provide additional benefit.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

December 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

December 21, 2013

Last Update Submit

June 8, 2016

Conditions

Selective Cannulation Rate of Trainees Receiving ERCP Training

Keywords

ERCP, trainning, trainees, EMS

Outcome Measures

Primary Outcomes (1)

  • Success rate of selective cannulation in 10min by trainee

    2 years

Secondary Outcomes (5)

  • Total time of successful cannulation

    2 years

  • Cumulative success rate of each month

    2 years

  • Performance score of selective cannulation

    2 years

  • Performance score of EST

    2 years

  • Complication rate

    2 years

Study Arms (2)

Hands-on EMS training group

EXPERIMENTAL
Device: Hands-on EMS trainingOther: Standard training

Standard training group

ACTIVE COMPARATOR
Other: Standard training

Interventions

Hands-on EMS trainingDEVICE

A trainer (SAH) gave a series of demonstrations of the proper techniques of ERCP step by step on the EMS. The demonstration included selective cannulation, sphincterotomy, guidewire exchange, balloon dilation, stone extraction and stent insertion. Then trainees practiced each technique with hands-on coaching from the trainer on the EMS. Each trainee could repeate the practice with the trainer giving only verbal correction of any errors for about 30min.

Hands-on EMS training group
Standard trainingOTHER

The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of CBD or PD. During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within 10min, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation.

Hands-on EMS training groupStandard training group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • consecutive inpatients with naive papilla undergoing ERCP.

You may not qualify if:

  • history of partial or total gastrectomy (Billroth I/II, Roux-en-Y);
  • duodenal stricture (benign or melignant);
  • ampullary carcinoma;
  • previously failed selective cannulation;
  • chronic pancreatitis with PD stone;
  • minor papilla cannulation;
  • servere diseases of heart, lung, brain and kidney;
  • hemodynamical unstablility;
  • pregnant women;
  • refusal or unable to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, 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: 23897401BACKGROUND

  • 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: 20978485BACKGROUND

Study Officials

  • Yanglin Pan, M.D.

    Xijing Hospital of Digestive Diseases.The Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

December 21, 2013

First Posted

December 30, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations

CN(1)