University Hospital - St. Michael's Hospital, Bratislava
Bratislava, 81108, Slovakia
Location status: Recruiting
Location contact
Barbora Norek, MD, PhD
CONTACT
Branislav Kuncak, MD
CONTACT
Branislav Kuncak, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07244432
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bratislava, 81108, Slovakia
Location status: Recruiting
Barbora Norek, MD, PhD
CONTACT
Branislav Kuncak, MD
CONTACT
Branislav Kuncak, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 48 hours after the procedure.
Time frame: Every 7 days until hospital discharge.
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.
Time frame: Periprocedurally
Includes age, sex, ERCP indication, and ESGE-defined patient- and procedure-related risk factors
Time frame: Up to 30 days post-procedure.
Contact information is provided by the study sponsor or research team.
Branislav Kuncak, MD
CONTACT
Rastislav Hustak, MD, Ph.D
CONTACT
Branislav Kuncak
Other
Post-ERCP Pancreatitis- Prophylactic Measures Implementation Study
Acronym: PEP-PROMIS
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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