Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees (ERCP)

Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees: a Prospectively Randomized, Controlled Study

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.

Study Overview

• Status: Suspended
• Conditions: Selective Cannulation Rate of Trainees Receiving ERCP Training
• Intervention / Treatment: Device: Hands-on EMS training; Other: Standard training

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• consecutive inpatients with naive papilla undergoing ERCP.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hands-on EMS training group	Device: Hands-on EMS training; 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.; Other: Standard training; 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.
Active Comparator: Standard training group	Other: Standard training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate of selective cannulation in 10min by trainee	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Yanglin Pan, M.D., Xijing Hospital of Digestive Diseases.The Fourth Military Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 21, 2013
• First Submitted That Met QC Criteria: December 21, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: ERCP, trainning, trainees, EMS
• Other Study ID Numbers: 20131208-4 (Other Identifier: Ethics committee of Xijing Hospital)