Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)
Recruiting now
Conditions studied: Pancreatitis, Acute, ERCP, Prophylaxis
In brief
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.
Key facts
- Study ID
- NCT07244432
- Run by
- Branislav Kuncak
- People needed
- 1000
- Starts
- 2025-12-01
- Expected to finish
- 2026-05-31
- Last updated by the study team
- 2026-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- University Hospital - St. Michael's Hospital, Bratislava — Bratislava, Slovakia (enrolling)
Full record on ClinicalTrials.gov
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