NCT07244432 Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)
| NCT ID | NCT07244432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Branislav Kuncak |
| Condition | Pancreatitis, Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-12-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Jan Martinek, Prof, MD, Ph.D
STUDY CHAIR
Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic
Frequently Asked Questions
Who can join the NCT07244432 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatitis, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07244432 currently recruiting?
Yes, NCT07244432 is actively recruiting participants. Contact the research team at branislav.kuncak@nsmas.sk for enrollment information.
Where is the NCT07244432 trial being conducted?
This trial is being conducted at Bratislava, Slovakia.
Who is sponsoring the NCT07244432 clinical trial?
NCT07244432 is sponsored by Branislav Kuncak. The principal investigator is Jan Martinek, Prof, MD, Ph.D at Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic. The trial plans to enroll 1,000 participants.