Selective Cannulation Rate of Trainees Receiving ERCP TrainingERCPNCT02022605
Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees
A study testing Hands-on EMS training and Standard training in people with Selective Cannulation Rate of Trainees Receiving ERCP Training, run by Air Force Military Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Selective Cannulation Rate of Trainees Receiving ERCP Training
- What is being tested?
- Hands-on EMS training and Standard training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Dec 2016
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive inpatients with naive papilla undergoing ERCP.
Who cannot join
- 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;
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- servere diseases of heart, lung, brain and kidney;
- hemodynamical unstablility;
- pregnant women;
- refusal or unable to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees: a Prospectively Randomized, Controlled Study
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.
- Being tested
- Hands-on EMS training, Standard training
- Keywords
- ERCP, trainning, trainees, EMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-on EMS trainingDevice
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.
Standard trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hands-on EMS training group | Experimental | Not described Receives: Device: Hands-on EMS training; Other: Standard training |
| Standard training group | Active comparator | Not described Receives: Other: Standard training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of selective cannulation in 10min by trainee
Measured: 2 years
Secondary outcomes (5)
Total time of successful cannulation
Measured: 2 years
Cumulative success rate of each month
Measured: 2 years
Performance score of selective cannulation
Measured: 2 years
Performance score of EST
Measured: 2 years
Complication rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Selective Cannulation Rate of Trainees Receiving ERCP 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Yanglin Pan, M.D., Principal investigator, Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022605
- Sponsor's protocol ID
- 20131208-4
- Other IDs
- 20131208-4
- Acronym
- ERCP
- Status last verified
- Jun 2016
- First submitted
- 21 Dec 2013
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees: a Prospectively Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02022605
- Acronym / sponsor ID
- ERCP / 20131208-4
- Keywords
- ERCP, trainning, trainees, EMS
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Dec 2013 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hands-on EMS training group | Experimental | Device: Hands-on EMS training, Other: Standard training |
| Standard training group | Active comparator | Other: Standard training |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive inpatients with naive papilla undergoing ERCP.
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| Hands-on EMS trainingA 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. | Device | Hands-on EMS training group |
| Standard trainingThe 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. | Other | Hands-on EMS training group, Standard training group |
Primary outcome
Success rate of selective cannulation in 10min by trainee
Time frame: 2 years
5 secondary outcomes
Total time of successful cannulation
Time frame: 2 years
Cumulative success rate of each month
Time frame: 2 years
Performance score of selective cannulation
Time frame: 2 years
Performance score of EST
Time frame: 2 years
Complication rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Background: 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.
- Background: 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.
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.
Yanglin Pan, M.D. principal investigator
Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hands-on EMS training and Standard training in people with Selective Cannulation Rate of Trainees Receiving ERCP Training, run by Air Force Military Medical University, China 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 10 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: paused, as of the sponsor's last update on 9 Jun 2016. 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?
Results are not available in the source record.
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 selective cannulation in 10min by trainee (time frame: 2 years). 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 NCT02022605, 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 9 Jun 2016.