About this trial
This is a prospective, observational (non-interventional), multicenter study that will look at how often inflammation of the pancreas (called post-ERCP pancreatitis, or PEP) occurs after an endoscopic procedure known as ERCP. The study will take place in several hospitals in Slovakia and Czechia and will include all patients who have this procedure during the study period.
ERCP is a common procedure used to treat problems in the bile ducts and pancreas. Although generally safe, it sometimes leads to PEP, which is the most frequent and potentially serious complication. Monitoring the rate of PEP helps doctors evaluate the overall quality of ERCP procedures, since patient safety is an important part of quality care.
The study will also look at how well hospitals follow current prevention guidelines from two major professional organizations-the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE)-and how these prevention methods affect the risk of PEP. This information will help identify how closely real-world practice follows recommended preventive measures and provide new data about PEP rates in the region.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ERCP in a patient with a native papilla (first ERCP) or repeat ERCP in a patient with previous failed cannulation attempt.
Age at least 18 years at the time of ERCP.
Signed informed consent.
Disqualifiers
Previous papillotomy, papilla dilation, or sphincteroplasty.
Rendez-vous cannulation technique.
ERCP not performed due to insufficient patient cooperation.
ERCP terminated before cannulation due to sedation/anesthesia-related complications.
Trial population
All consecutive adults undergoing ERCP at participating centers. Selected ERCP centers within the Slovakia and Czechia. The centers selected for this study are those that expressed interest in participating based on our yet unpublished 2024 survey, which aimed to assess how ERCP quality parameters were monitored and how prophylactic measures for PEP were implemented across centers. A total of 26 ERCP centers participated in the survey, including 14 from Slovakia and 12 from Czechia. Centers that expressed interest, as well as all remaining ERCP-performing centers in Slovakia and several in Czechia, were subsequently contacted by email with information about the study and invited to participate.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Percentage of participants who develop post-ERCP pancreatitis.
Secondary outcomes
Percentage of participants experiencing none, mild, moderate, or severe post-ERCP pancreatitis.
Proportion of ERCP procedures in which one or more guideline-recommended preventive measures are used.
Number of participants stratified by predefined patient- and procedure-related risk factors and occurrence of post-ERCP pancreatitis
Includes age, sex, ERCP indication, and ESGE-defined patient- and procedure-related risk factors
Number of participants with PEP-related mortality during index hospitalization or within 30 days after ERCP.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Branislav Kuncak
Lead sponsor
University Hospital Bratislava
Sponsor institution