Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatitis, Acute, ERCP, Prophylaxis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovakia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-ERCP Pancreatitis- Prophylactic Measures Implementation Study
Overview
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.
Primary outcome measures
- Percentage of participants who develop post-ERCP pancreatitis. [Time frame: 48 hours after the procedure.]
Secondary outcome measures (4)
- Percentage of participants experiencing none, mild, moderate, or severe post-ERCP pancreatitis. [Time frame: Every 7 days until hospital discharge.]
- 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.]
- Number of participants stratified by predefined patient- and procedure-related risk factors and occurrence of post-ERCP pancreatitis [Time frame: Periprocedurally]
- Number of participants with PEP-related mortality during index hospitalization or within 30 days after ERCP. [Time frame: Up to 30 days post-procedure.]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Slovakia · 1 center
- University Hospital - St. Michael's Hospital, Bratislava — Bratislava
Identifiers
NCT: NCT07244432 · NSM-BA-PEP-PROMIS