Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1283 participants
OBSERVATIONAL
2020-04-01
2022-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Trainee Group
Patients who undergo ERCPs with trainee involvement
ERCP
endoscopic retrograde cholangiopancreatography
control group
Patients who undergo ERCPs without any trainee involvement
ERCP
endoscopic retrograde cholangiopancreatography
Interventions
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ERCP
endoscopic retrograde cholangiopancreatography
Eligibility Criteria
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Inclusion Criteria
* informed consent signed prior to the procedure
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Policlinico Gemelli, Rome, Italy
UNKNOWN
Cantacuzino Clinical Hospital, Bucharest, Romania
UNKNOWN
Zadar Hospital, Zadar, Croatia
UNKNOWN
University of Belgrade
OTHER
UHC Zagreb, Zagreb, Croatia
OTHER_GOV
Oxford University Hospitals NHS Trust
OTHER
University of Colorado, Denver, USA
UNKNOWN
Medical University, Sofia, Bulgaria
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
ISUL Hospital, Sofia, Bulgaria
UNKNOWN
Clinical Hospital Colentina
OTHER
Responsible Party
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dr. Theodor Alexandru Voiosu
MD, PhD
Principal Investigators
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theodor voiosu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Colentina Clinical Hospital, UMF Carol Davila Faculty of Medicine
Locations
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Colentina Clinical Hospital
Bucharest, , Romania
Countries
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References
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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.
Other Identifiers
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TIERS
Identifier Type: -
Identifier Source: org_study_id
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