Actively Recruiting
Post-ERCP Pancreatitis Prophylactic Measures Implementation Study
Led by Branislav Kuncak · Updated on 2026-02-20
1000
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, observational study across multiple centers in Slovakia and Czechia to understand how often inflammation of the pancreas, called post-ERCP pancreatitis (PEP), occurs after an endoscopic procedure known as ERCP. The study aims to monitor PEP rates as a measure of patient safety and quality of care during ERCP, which is used to treat bile duct and pancreas problems. It will also evaluate how well hospitals follow prevention guidelines from major professional societies and how these measures impact the risk of PEP. The study includes adult patients undergoing their first ERCP or a repeat ERCP after a previous failed cannulation. Patients with certain prior procedures, anatomical issues, or complications preventing standard ERCP are excluded. The ERCP procedure is performed under analgosedation or general anesthesia based on patient condition and hospital protocols. This observational study does not involve experimental treatments but carefully records the procedures and preventive measures used. Participants will be observed closely for the development of PEP up to 48 hours post-procedure, with severity assessments every 7 days until hospital discharge. The study tracks the use of recommended preventive measures before, during, or shortly after ERCP, monitors risk factors, and records any PEP-related death within 30 days. This data will help improve understanding of PEP occurrence and prevention in real-world clinical settings.
CONDITIONS
Brief Title
Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ERCP in a patient with a native papilla (first ERCP) or 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
- Insufficient patient cooperation preventing ERCP
- ERCP terminated before cannulation due to sedation or anesthesia complications
- Failure to reach the major or minor papilla (e.g., duodenal stenosis)
- Acute biliary pancreatitis
- Altered anatomy preventing access to the papilla with a standard duodenoscope (e.g., Roux-en-Y reconstruction)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) before ERCP procedure
Duration - Day of the ERCP procedure
Participants undergo the ERCP procedure to assess and treat pancreatic and biliary conditions.
1 visit (in-person) for the ERCP procedure
Duration - Up to 30 days after the ERCP procedure
Participants are monitored for the development of post-ERCP pancreatitis and other complications.
Daily assessments for up to 7 days until hospital discharge and follow-up monitoring up to 30 days
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
R
Rastislav Hustak, MD, Ph.D
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here