Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBranislav Kuncak

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group

Sponsors and collaborators

Branislav Kuncak

Lead sponsor

University Hospital Bratislava

Sponsor institution