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

Selective Cannulation Rate of Trainees Receiving ERCP Training Clinical Trial

— ERCP  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02022605
• Other study ID #: 20131208-4
• Secondary ID: 20131208-4
• Status: Suspended
• Phase: N/A
• First received: December 21, 2013
• Last updated: June 8, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 400
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Selective Cannulation Rate of Trainees Receiving ERCP Training

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of selective cannulation in 10min by trainee		2 years	No
Secondary	Total time of successful cannulation		2 years	No
Secondary	Cumulative success rate of each month		2 years	No
Secondary	Performance score of selective cannulation		2 years	No
Secondary	Performance score of EST		2 years	No
Secondary	Complication rate		2 years	Yes