Hands-on TrainingNCT02838498
Practice With Simulator Improves Basic ERCP Skills of Surgical Trainees
A study testing ERCP Mechanical Simulator (EMS) in people with Hands-on Training, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Hands-on Training
- What is being tested?
- ERCP Mechanical Simulator (EMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to 26 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No experienced surgical trainees receiving ERCP training
Who cannot join
- Experienced surgical ERCP trainees or who are not receiving ERCP training
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
Official title: Practice With ERCP Mechanical Simulator (EMS) Improves Basic ERCP Skills of Novice Surgical Trainees
To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.
Read the detailed description
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.
- Conditions
- Hands-on Training
- Being tested
- ERCP Mechanical Simulator (EMS)
- Keywords
- ERCP, EMS, Cannulation, Successful rate, Trainee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP Mechanical Simulator (EMS)Device
Hands on EMS training
| Study group | Role | What they receive |
|---|---|---|
| Intensive EMS training group | Experimental | 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. Receives: Device: ERCP Mechanical Simulator (EMS) |
| Routine ERCP training group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Intubation time before cannulation
during the scope explored to cannulation
Measured: 12 months
Successful cannulation time from first achieve the papilla
the time between the first achieve the papilla to cannulate successfully
Measured: 12 months
Total time
From scope explored to withdraw
Measured: 12 months
performance score of selective cannulation
The ability of trainees to perform solo diagnostic biliary cannulation and deep cannulation
Measured: 12 months
Complication rate
The rate of major complications
Measured: 12 months
Trainer assessment
Subjective competency graded by supervising physicians as above average, average or below average based on objective criteria.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion26 Dec 2018
- Study completion26 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hands-on TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xun Li, M.D., Ph. D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838498
- Sponsor's protocol ID
- Surgical ERCP EMS training
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2016
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23897401Lim 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.
PubMed 20978485
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice With ERCP Mechanical Simulator (EMS) Improves Basic ERCP Skills of Novice Surgical Trainees
- ClinicalTrials.gov ID
- NCT02838498
- Acronym / sponsor ID
- Surgical ERCP EMS training
- Conditions
- Hands-on Training
- Keywords
- ERCP, EMS, Cannulation, Successful rate, Trainee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive EMS training group | Experimental | Device: ERCP Mechanical Simulator (EMS)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. |
| Routine ERCP training group | No intervention | –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. |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No experienced surgical trainees receiving ERCP training
Key exclusion criteria (1 listed)
- Experienced surgical ERCP trainees or who are not receiving ERCP training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP Mechanical Simulator (EMS)Hands on EMS training | Device | Intensive EMS training group |
Primary outcome
Success rate of bile duct cannulation
Time frame: 12 months
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.
6 secondary outcomes
Intubation time before cannulation
Time frame: 12 months
Successful cannulation time from first achieve the papilla
Time frame: 12 months
Total time
Time frame: 12 months
performance score of selective cannulation
Time frame: 12 months
Complication rate
Time frame: 12 months
Trainer assessment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Results publication: PubMed 23897401Liao 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.
- Results publication: PubMed 20978485Lim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xun Li, M.D., Ph. D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP Mechanical Simulator (EMS) in people with Hands-on Training, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of bile duct cannulation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838498, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.