Skip to main content
OpenTrials
Completed

NCT Number: NCT02698137

Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cholangiopancreatography, Endoscopic Retrograde Bile Duct and Pancreatic Tumors Biliary Strictures Common Bile Duct Lithiasis Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb, Zagreb, Croatia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • refusal to sign the informed consent

Treatment and study plan

Primary outcomes

  1. procedure-related adverse events

    Time frame: 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 outcomes

  1. technical failure of the procedure

    Time frame: 30 days

    percentage of procedures where the operator was unable to achieve the desired therapeutic goal (i.e selective cannulation, stone removal, stenting)

Sponsors and collaborators

Lead sponsor

Clinical Hospital Colentina

Other

Registry information

Official study title

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

Acronym: QUASIE2

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2016
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.