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Trainee Involvement in ERCP Risk Score

Trainee Involvement in ERCP Risk Score

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04341909
Acronym
TIERS
Enrollment
1283
Registered
2020-04-10
Start date
2020-04-01
Completion date
2022-01-01
Last updated
2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Diseases, Pancreas Cancer

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.

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.

Interventions

PROCEDUREERCP

endoscopic retrograde cholangiopancreatography

Sponsors

Policlinico Gemelli, Rome, Italy
CollaboratorUNKNOWN
Cantacuzino Clinical Hospital, Bucharest, Romania
CollaboratorUNKNOWN
Zadar Hospital, Zadar, Croatia
CollaboratorUNKNOWN
University of Belgrade
CollaboratorOTHER
UHC Zagreb, Zagreb, Croatia
CollaboratorOTHER_GOV
Oxford University Hospitals NHS Trust
CollaboratorOTHER
University of Colorado, Denver, USA
CollaboratorUNKNOWN
Medical University, Sofia, Bulgaria
CollaboratorUNKNOWN
Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
ISUL Hospital, Sofia, Bulgaria
CollaboratorUNKNOWN
Clinical Hospital Colentina
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients undergoing ERCP in the participating centers * informed consent signed prior to the procedure

Exclusion criteria

* refusal to participate / sign the informed consent

Design outcomes

Primary

MeasureTime frameDescription
any procedure related adverse outcome30 daysincluding but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026