ERCP, Pancreatitis, Acute, Prophylaxis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Branislav Kuncak
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Failure to reach the Vater's or minor papilla (e.g. duodenal stenosis). * Acute biliary pancreatitis. * Altered anatomy that prevents reaching the papilla with a standard duodenoscope (e.g. Roux-en-Y).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who develop post-ERCP pancreatitis. | 48 hours after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with PEP-related mortality during index hospitalization or within 30 days after ERCP. | Up to 30 days post-procedure. | — |
| Percentage of participants experiencing none, mild, moderate, or severe post-ERCP pancreatitis. | Every 7 days until hospital discharge. | — |
| Proportion of ERCP procedures in which one or more guideline-recommended preventive measures are used. | Periprocedural preventive measures applied immediately before, during, or shortly after the ERCP procedure. Aggressive hydration may continue for up to 8 hours post-procedure. | — |
| Number of participants stratified by predefined patient- and procedure-related risk factors and occurrence of post-ERCP pancreatitis | Periprocedurally | Includes age, sex, ERCP indication, and ESGE-defined patient- and procedure-related risk factors |
Countries
Czechia, Slovakia
Contacts
STUDY_CHAIRJan Martinek, Prof, MD, Ph.D
Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic
PRINCIPAL_INVESTIGATORBranislav Kunčak, MUDr.
St. Michael´s University Hospital and Slovak Health University, Bratislava, Slovakia
Outcome results
None listed