Trainee Involvement in ERCP Risk Score
TIERS
1 other identifier
observational
1,283
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedJune 7, 2022
June 1, 2022
1.5 years
April 8, 2020
June 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
any procedure related adverse outcome
including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis
30 days
Study Arms (2)
Trainee Group
Patients who undergo ERCPs with trainee involvement
control group
Patients who undergo ERCPs without any trainee involvement
Interventions
Eligibility Criteria
all adult patients undergoing ERCP for any indication (diagnostic / therapeutic) in the participating centers
You may qualify if:
- patients undergoing ERCP in the participating centers
- informed consent signed prior to the procedure
You may not qualify if:
- refusal to participate / sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinical Hospital Colentinalead
- Policlinico Gemelli, Rome, Italycollaborator
- Cantacuzino Clinical Hospital, Bucharest, Romaniacollaborator
- Zadar Hospital, Zadar, Croatiacollaborator
- University of Belgradecollaborator
- UHC Zagreb, Zagreb, Croatiacollaborator
- Oxford University Hospitals NHS Trustcollaborator
- University of Colorado, Denver, USAcollaborator
- Medical University, Sofia, Bulgariacollaborator
- Universitaire Ziekenhuizen KU Leuvencollaborator
- ISUL Hospital, Sofia, Bulgariacollaborator
Study Sites (1)
Colentina Clinical Hospital
Bucharest, Romania
Related Publications (1)
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.
PMID: 31766060BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
theodor voiosu, MD, PhD
Colentina Clinical Hospital, UMF Carol Davila Faculty of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 10, 2020
Study Start
April 1, 2020
Primary Completion
September 30, 2021
Study Completion
January 1, 2022
Last Updated
June 7, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share