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NCT Number: NCT07244432

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Percentage of participants who develop post-ERCP pancreatitis.

    Time frame: 48 hours after the procedure.

Secondary outcomes

  1. Percentage of participants experiencing none, mild, moderate, or severe post-ERCP pancreatitis.

    Time frame: Every 7 days until hospital discharge.

  2. Proportion of ERCP procedures in which one or more guideline-recommended preventive measures are used.

    Time frame: Periprocedural preventive measures applied immediately before, during, or shortly after the ERCP procedure. Aggressive hydration may continue for up to 8 hours post-procedure.

  3. Number of participants stratified by predefined patient- and procedure-related risk factors and occurrence of post-ERCP pancreatitis

    Time frame: Periprocedurally

    Includes age, sex, ERCP indication, and ESGE-defined patient- and procedure-related risk factors

  4. Number of participants with PEP-related mortality during index hospitalization or within 30 days after ERCP.

    Time frame: Up to 30 days post-procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Branislav Kuncak, MD

CONTACT

[email protected]

+421232611113

Rastislav Hustak, MD, Ph.D

CONTACT

[email protected]

+421335938810

Sponsors and collaborators

Lead sponsor

Branislav Kuncak

Other

Registry information

Official study title

Post-ERCP Pancreatitis- Prophylactic Measures Implementation Study

Acronym: PEP-PROMIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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