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

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Suspended

CT.gov ID

NCT02022605

Collaborator

(none)

400

Enrollment

Location

Arms

Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Selective Cannulation Rate of Trainees Receiving ERCP Training	Device: Hands-on EMS training Other: Standard training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

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

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Success rate of selective cannulation in 10min by trainee [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

Air Force Military Medical University, China

Investigators

Principal Investigator: Yanglin Pan, M.D., Xijing Hospital of Digestive Diseases.The Fourth Military Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Yanglin Pan, Associated professor, Air Force Military Medical University, China

ClinicalTrials.gov Identifier:

NCT02022605

Other Study ID Numbers:

20131208-4
20131208-4

First Posted:

Dec 30, 2013

Last Update Posted:

Jun 9, 2016

Last Verified:

Jun 1, 2016

Keywords provided by Yanglin Pan, Associated professor, Air Force Military Medical University, China

ERCP, trainning, trainees, EMS

Study Results

No Results Posted as of Jun 9, 2016