Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP) (QUASIE2)
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|ClinicalTrials.gov Identifier: NCT02698137|
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : April 9, 2020
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.
|Condition or disease|
|Cholangiopancreatography, Endoscopic Retrograde Common Bile Duct Lithiasis Biliary Strictures Bile Duct and Pancreatic Tumors|
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.
|Study Type :||Observational|
|Actual Enrollment :||1843 participants|
|Official Title:||Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||July 2019|
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698137
|GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb|
|Zagreb, Croatia, 10000|
|Endoscopia Digestiva Chirurgica, Policlinico Gemelli|
|Gastroenterology Department, Colentina Hospital|
|Bucharest, Romania, 020125|
|Principal Investigator:||Theodor Voiosu, MD, PhD||Clinical Hospital Colentina|