Preventing pancreatitis after ERCP: tracking prevention and outcomes
Post-ERCP Pancreatitis- Prophylactic Measures Implementation Study
This project will track how often pancreatitis happens after ERCP and whether hospitals follow recommended prevention steps for adults having ERCP in Slovakia and Czechia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Bratislava Academic / other |
| Locations | 1 site (Bratislava) |
| Trial ID | NCT07244432 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-interventional, multicenter project enrolling adults who undergo ERCP at participating hospitals in Slovakia and Czechia. It will record occurrences of post-ERCP pancreatitis and collect data on use of guideline-recommended preventive measures such as rectal NSAIDs, prophylactic pancreatic stents, and hydration. The study includes patients with a native papilla or repeat ERCP after a prior failed cannulation and excludes cases with prior papillotomy, altered anatomy preventing standard access, acute biliary pancreatitis, or aborted procedures. Clinicians provide usual care and the collected data will be used to compare PEP rates and guideline adherence across centers as a quality measure.
Who should consider this trial
Good fit: Adults (≥18 years) undergoing ERCP with a native papilla or a repeat ERCP after a failed cannulation who can give informed consent at participating centers in Slovakia or Czechia.
Not a fit: Patients with prior papillotomy, papilla dilation or sphincteroplasty, altered anatomy that prevents reaching the papilla with a standard duodenoscope, acute biliary pancreatitis, or incomplete/aborted ERCP are excluded and therefore unlikely to benefit from this project's findings.
Why it matters
Potential benefit: If successful, this work could reveal gaps in prevention practice and help hospitals reduce post-ERCP pancreatitis by improving adherence to proven prophylactic measures.
How similar studies have performed: Randomized trials and international guidelines have shown that measures like rectal NSAIDs and prophylactic pancreatic stents reduce PEP risk, so monitoring implementation is an established quality-improvement approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bratislava
- University Hospital - St. Michael's Hospital, Bratislava — Bratislava, Slovakia (Recruiting)
Study contacts
- Principal investigator: Branislav Kunčak, MUDr. — St. Michael´s University Hospital and Slovak Health University, Bratislava, Slovakia
- Study coordinator: Branislav Kuncak, MD
- Email: branislav.kuncak@nsmas.sk
- Phone: +421232611113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.