Bile Duct DiseasesTIERSNCT04341909
Trainee Involvement in ERCP Risk Score
An observational study of Bile Duct Diseases and Pancreas Cancer, run by Clinical Hospital Colentina at 1 site in Romania.
Trial summary
The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Diseases, Pancreas Cancer
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 1,283 participants
- Where
- 1 siteRomania
- Study dates
- 1 Apr 2020to 1 Jan 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all adult patients undergoing ERCP for any indication (diagnostic / therapeutic) in the participating centers
Who may be able to join
- patients undergoing ERCP in the participating centers
- informed consent signed prior to the procedure
Who cannot join
- refusal to participate / sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.
Read the detailed description
The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.
It has previously shown that ERCP procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ERCP, including identifying some high risk features that might indicate that trainee involvement should not be warranted.
Briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting.
data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events.
Patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.
- Conditions
- Bile Duct Diseases, Pancreas Cancer
- Being tested
- ERCP
- Medical subject headings
- Bile Duct Diseases, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
endoscopic retrograde cholangiopancreatography
| Study group | Role | What they receive |
|---|---|---|
| Trainee Group | Patients who undergo ERCPs with trainee involvement Receives: Procedure: ERCP | |
| control group | Patients who undergo ERCPs without any trainee involvement Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
any procedure related adverse outcome
including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Sep 2021
- Study completion1 Jan 2022
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 Bile Duct DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,283 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Collaborators
- Policlinico Gemelli, Rome, Italy, Cantacuzino Clinical Hospital, Bucharest, Romania, Zadar Hospital, Zadar, Croatia, University of Belgrade, UHC Zagreb, Zagreb, Croatia, Oxford University Hospitals NHS Trust, University of Colorado, Denver, Medical University, Sofia, Bulgaria, Universitaire Ziekenhuizen KU Leuven, ISUL Hospital, Sofia, Bulgaria
- Responsible party
- Principal investigator, dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
- Investigators
- theodor voiosu, MD, PhD, Principal investigator, Colentina Clinical Hospital, UMF Carol Davila Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341909
- Sponsor's protocol ID
- TIERS
- Acronym
- TIERS
- Status last verified
- Jun 2022
- First submitted
- 8 Apr 2020
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Voiosu T, Boskoski I, Voiosu AM, Bengus A, Ladic A, Klarin I, Bove V, Busuioc B, Rimbas M, Rustemovic N, Mateescu B, Jovanovic I, Costamagna G. Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial. Endoscopy. 2020 Feb;52(2):115-122. doi: 10.1055/a-1049-0359. Epub 2019 Nov 25.
PubMed 31766060
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trainee Involvement in ERCP Risk Score
- ClinicalTrials.gov ID
- NCT04341909
- Acronym / sponsor ID
- TIERS / TIERS
- Conditions
- Bile Duct Diseases, Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,283 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Collaborators
- Policlinico Gemelli, Rome, Italy, Cantacuzino Clinical Hospital, Bucharest, Romania, Zadar Hospital, Zadar, Croatia, University of Belgrade, UHC Zagreb, Zagreb, Croatia, Oxford University Hospitals NHS Trust, University of Colorado, Denver, Medical University, Sofia, Bulgaria, Universitaire Ziekenhuizen KU Leuven, ISUL Hospital, Sofia, Bulgaria
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 10 Apr 2020 (actual)
- 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.
The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.
Detailed description
The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.
It has previously shown that ERCP procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ERCP, including identifying some high risk features that might indicate that trainee involvement should not be warranted.
Briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting.
data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events.
Patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trainee Group | – | Procedure: ERCPPatients who undergo ERCPs with trainee involvement |
| control group | – | Procedure: ERCPPatients who undergo ERCPs without any trainee involvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adult patients undergoing ERCP for any indication (diagnostic / therapeutic) in the participating centers
Key inclusion criteria (2 listed)
- patients undergoing ERCP in the participating centers
- informed consent signed prior to the procedure
Key exclusion criteria (1 listed)
- refusal to participate / sign the informed consent
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 |
|---|---|---|
| ERCPendoscopic retrograde cholangiopancreatography | Procedure or surgery | Trainee Group, control group |
Primary outcome
any procedure related adverse outcome
Time frame: 30 days
including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis
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 7 Jun 2022.
- Background: PubMed 31766060Voiosu T, Boskoski I, Voiosu AM, Bengus A, Ladic A, Klarin I, Bove V, Busuioc B, Rimbas M, Rustemovic N, Mateescu B, Jovanovic I, Costamagna G. Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial. Endoscopy. 2020 Feb;52(2):115-122. doi: 10.1055/a-1049-0359. Epub 2019 Nov 25.
- 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.
theodor voiosu, MD, PhD principal investigator
Colentina Clinical Hospital, UMF Carol Davila Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Diseases and Pancreas Cancer, run by Clinical Hospital Colentina at 1 site in Romania.
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 2 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 7 Jun 2022. 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 Romania. 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?
any procedure related adverse outcome (time frame: 30 days). 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 NCT04341909, 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 7 Jun 2022.