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Trainee Involvement in ERCP Risk Score — TIERS  

Pancreas Cancer Clinical Trial

Official title:
Trainee Involvement in ERCP Risk Score

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04341909
Study type Observational [Patient Registry]
Source Clinical Hospital Colentina
Contact
Status Completed
Phase
Start date April 1, 2020
Completion date January 1, 2022
View Details
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