Cholangiopancreatography, Endoscopic Retrograde Clinical Trial
Official title:
Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program
The investigators will prospectively collect patient and procedure-related data in an
observational study in order to detect patient and procedure-related risk factors for poor
outcome (i.e. technical failure of the procedure; procedure-related complications).
Data will be prospectively reported using standard report forms and patients will be followed
up to 30 days to detect late-onset complications.
This is an investigator-driven, prospective multicenter trial which analyzes the impact of
trainee participation on procedure-related outcome (technical success and procedure-related
complications).
All ERCPs in the participating centers will be documented using a standard report form which
will require the attending endoscopist to provide data relating to the patient (age, gender,
diagnosis, bilirubin levels) and the procedure (including but not limited to the indication,
technical aspects including cannulation technique, time to cannulation, degree of trainee
involvement - where appropriate, procedure-related adverse events and their outcome).
Because teaching ERCP is not yet a standardized procedure, we aim to assemble a large
database, stemming from the experience of several teaching centers in order to identify the
main patient and operator-related factors which might influence the outcome of the procedure.
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