Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP) (QUASIE2)

Clinical Hospital Colentina

Status

Completed

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Biliary Strictures

Bile Duct and Pancreatic Tumors

Common Bile Duct Lithiasis

Study type

Observational

Funder types

Other

Identifiers

NCT02698137

QUASIE2

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,843 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria