An interventional study of ERCP Mechanical Simulator (EMS) in Hands-on Training, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Completed at 1 site in China. Open to participants aged 26 Years and older. Per ClinicalTrials.gov, last updated 2019-07-11.
Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Not applicable, Interventional, and Treatment
To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.
Practicing Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using the EMS provides opportunities for novice endoscopists to learn basic ERCP skills without a patient. In two randomized controlled trials (RCT), coached EMS practice increased selective bile duct cannulation success rate of novice endoscopists. Surgical trainees do not have sufficient endoscopy experience to meet the perceived basic requirement for ERCP training. However, ERCP is done with a side-viewing scope and even experienced GI trainees have difficult initially mastering the basic skill with scope manipulation and cannulation. It is not known whether EMS can provide additional benefit to novice surgical ERCP trainees.
Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: ERCP mechanical simulator training EMS group was coached (by JWL) on how to use the EMS, and then practiced with supervision by a senior surgeon biliary endoscopist (WBM). Trainees practiced for a total of 20 hours performing basic maneuvers including scope insertion 2 hours, scope positioning 6 hours, selective guide wire cannulation of common bile duct (CBD) stricture or pancreatic duct (PD) 10 hours and placement of a biliary stent 2 hours. All trainees received hands-on supervised clinical ERCP practice on patients. Time taken to perform ERCP procedures was documented. Trainees received verbal instructions, hands-on assistance from the trainer in performing the clinical procedure. If the trainee still failed after 20 minutes, the trainer took over.
Device: ERCP Mechanical Simulator (EMS)
Other: Routine ERCP training group All trainees received hands-on supervised clinical ERCP practice on patients. Time taken to perform ERCP procedures was documented. Trainees received verbal instructions, hands-on assistance from the trainer in performing the clinical procedure. If the trainee still failed after 20 minutes, the trainer took over.
Hands on EMS training
Success rate of bile duct cannulation
Trainees received verbal instructions, hands-on assistance from the trainer no more than three times in performing the clinical procedure. The trainer took over if the trainee still failed after 20 minutes.
Time frame: 12 months
Intubation time before cannulation
during the scope explored to cannulation
Time frame: 12 months
Successful cannulation time from first achieve the papilla
the time between the first achieve the papilla to cannulate successfully
Time frame: 12 months
Total time
From scope explored to withdraw
Time frame: 12 months
performance score of selective cannulation
The ability of trainees to perform solo diagnostic biliary cannulation and deep cannulation
Time frame: 12 months
Complication rate
The rate of major complications
Time frame: 12 months
Trainer assessment
Subjective competency graded by supervising physicians as above average, average or below average based on objective criteria.
Time frame: 12 months
Plan to share: No
The record gives a start of Jul 2016, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hepatopancreatobiliary Surgery Institute of Gansu Province