Actively Recruiting
Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)
Led by Branislav Kuncak · Updated on 2026-02-20
1000
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ERCP performed on a patient with a native papilla (first ERCP) or a repeat ERCP after a previous failed cannulation attempt.
- Age 18 years or older at the time of ERCP.
- Signed informed consent provided.
You will not qualify if you...
- Previous papillotomy, papilla dilation, or sphincteroplasty.
- Use of rendez-vous cannulation technique.
- ERCP not performed due to lack of patient cooperation.
- ERCP stopped before cannulation because of sedation or anesthesia complications.
- Failure to reach Vater's or minor papilla (e.g., due to duodenal stenosis).
- Acute biliary pancreatitis.
- Altered anatomy preventing access to papilla with standard duodenoscope (e.g., Roux-en-Y).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital - St. Michael's Hospital, Bratislava
Bratislava, Slovakia, 81108
Actively Recruiting
Research Team
B
Branislav Kuncak, MD
CONTACT
R
Rastislav Hustak, MD, Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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