Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)
Slovakia1,000 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants who develop post-ERCP pancreatitis.