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

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02022605
Acronym
ERCP
Enrollment
400
Registered
2013-12-30
Start date
2013-12-31
Completion date
2016-12-31
Last updated
2016-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selective Cannulation Rate of Trainees Receiving ERCP Training

Keywords

ERCP, trainning, trainees, EMS

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.

Interventions

DEVICEHands-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.

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.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Success rate of selective cannulation in 10min by trainee2 years

Secondary

MeasureTime frame
Total time of successful cannulation2 years
Cumulative success rate of each month2 years
Performance score of selective cannulation2 years
Performance score of EST2 years
Complication rate2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026