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

NCT07244432 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Pancreatitis, Acute
  • ERCP
  • Prophylaxis

Sponsors & Collaborators

  • Branislav Kuncak

    lead OTHER

Principal Investigators

  • Jan Martinek, Prof, MD, Ph.D · Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic

  • Branislav Kunčak, MUDr. · St. Michael´s University Hospital and Slovak Health University, Bratislava, Slovakia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-04-30
Completion
2026-05-31

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07244432 on ClinicalTrials.gov