Endoscopic SphincterotomyNCT02393638
ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy
A study testing Simulation and lecture and Lecture in people with Endoscopic Sphincterotomy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Endoscopic Sphincterotomy
- What is being tested?
- Simulation and lecture and Lecture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to May 2015
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GI trainees who met the minimum endoscopy training experience
Who cannot join
- GI trainees with no endoscopy experience
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, National Taiwan University Hospital
Taipei
W C Liao, MD, 886 2 23123456 ext. 63356, david.ntuh@gmail.com
W C Liao, MD
About this study
This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy.
Read the detailed description
Usual clinical ERCP training is supervised hands-on practice and the number of procedures is used as a surrogate for trainees' experience. At least 180 cases are required to achieve ERCP competence. A major limitation is lack of suitable patients. Alternative supplemental training includes simulator practice using computer simulators, live animal models, and ex-vivo porcine organ. Our previous study has showed that the mechanical simulator training improves trainees' clinical performance in terms of success of deep CBD cannulation. In this study, we aim to evaluate the usefulness of ERCP mechanical simulator for training endoscopic sphincterotomy.
- Conditions
- Endoscopic Sphincterotomy
- Being tested
- Simulation and lecture, Lecture
- Keywords
- Endoscopic Sphincterotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation and lectureOther
Endoscopic sphincterotomy on simulator and lecture
LectureOther
Lecture
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Simulation and lecture Receives: Other: Simulation and lecture |
| control group | Active comparator | Lecture only Receives: Other: Lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of endoscopic sphincterotomy successfully performed by trainees
Measured: 1year
Secondary outcomes (1)
Improvement in overall performance as measured by sphincterotomy score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic SphincterotomyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- W C Liao, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393638
- Sponsor's protocol ID
- 201403004RIND
- Status last verified
- Mar 2015
- First submitted
- 10 Feb 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- 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 23897401
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy
- ClinicalTrials.gov ID
- NCT02393638
- Acronym / sponsor ID
- 201403004RIND
- Conditions
- Endoscopic Sphincterotomy
- Keywords
- Endoscopic Sphincterotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 19 Mar 2015 (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.
This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy.
Detailed description
Usual clinical ERCP training is supervised hands-on practice and the number of procedures is used as a surrogate for trainees' experience. At least 180 cases are required to achieve ERCP competence. A major limitation is lack of suitable patients. Alternative supplemental training includes simulator practice using computer simulators, live animal models, and ex-vivo porcine organ. Our previous study has showed that the mechanical simulator training improves trainees' clinical performance in terms of success of deep CBD cannulation. In this study, we aim to evaluate the usefulness of ERCP mechanical simulator for training endoscopic sphincterotomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Simulation and lectureSimulation and lecture |
| control group | Active comparator | Other: LectureLecture only |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- GI trainees who met the minimum endoscopy training experience
Key exclusion criteria (1 listed)
- GI trainees with no endoscopy experience
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 |
|---|---|---|
| Simulation and lectureEndoscopic sphincterotomy on simulator and lecture | Other | study group |
| LectureLecture | Other | control group |
Primary outcome
proportion of endoscopic sphincterotomy successfully performed by trainees
Time frame: 1year
1 secondary outcome
Improvement in overall performance as measured by sphincterotomy score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- 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.
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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.
W C Liao, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation and lecture and Lecture in people with Endoscopic Sphincterotomy, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 19 Mar 2015. 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 Taiwan. 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?
Contact W C Liao, MD (886-2-23123456 ext. 63356, david.ntuh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of endoscopic sphincterotomy successfully performed by trainees (time frame: 1year). 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 NCT02393638, which also lists 1 linked publication.
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 19 Mar 2015.