Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02698137

Acronym

QUASIE2

Enrollment

1843

Registered

2016-03-03

Start date

2016-03-31

Completion date

2019-07-31

Last updated

2020-04-09

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

Conditions

Bile Duct and Pancreatic Tumors, Biliary Strictures, Cholangiopancreatography, Endoscopic Retrograde, Common Bile Duct Lithiasis

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* all patients undergoing ERCP with attempted cannulation of either the major or minor papilla

Exclusion criteria

* refusal to sign the informed consent

Design outcomes

Primary

Measure	Time frame	Description
procedure-related adverse events	30 days	the percentage of patients experiencing procedure-related adverse events (i.e post-ERCP pancreatitis; postERCP cholangitis; perforation; postERCP bleeding or death) occuring within 30 days of the procedure

Secondary

Measure	Time frame	Description
technical failure of the procedure	30 days	percentage of procedures where the operator was unable to achieve the desired therapeutic goal (i.e selective cannulation, stone removal, stenting)

Countries

Croatia, Italy, Romania

Outcome results