About this trial
This pilot clinical study aims to assess the feasibility and clinical relevance of bedside monitoring of microenvironmental conditions within infected walled-off pancreatic necrosis (WOPN).
WOPN is a serious complication of acute pancreatitis, often associated with infection, organ failure, and the need for drainage or surgical intervention. Although infection is a key factor in prognosis, little is known about the local chemical environment inside the infected collections.
In this study, a sterile, miniaturized probe will be temporarily introduced into the necrotic cavity during standard percutaneous drainage. The goal is to record local microenvironmental parameters (such as acidity or related values) and monitor their changes over time.
By comparing these values with clinical data (e.g., inflammatory markers, microbiology, need for surgery), the study aims to determine whether such measurements can provide additional information about infection severity and treatment response.
The study does not involve any experimental treatment. All patients will receive standard medical care, including antibiotics, imaging, and drainage according to international guidelines.
Participation is voluntary. Only patients who provide informed consent will be enrolled.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Diagnosis of walled-off pancreatic necrosis (WOPN) confirmed by imaging (CT, MRI, or EUS)
Clinical suspicion or confirmation of infection in WOPN (e.g., fever, elevated inflammatory markers, positive culture)
Planned percutaneous drainage as part of standard care
Disqualifiers
Coagulopathy not correctable prior to intervention (e.g., INR > 2.0 or platelets < 50×10⁹/L)
Known allergy or hypersensitivity to materials used in the monitoring probe
technical limitations precluding safe probe insertion
Trial design
Treatments tested in this trial
- Miniaturized Intracavitary Monitoring Probe
Treatment groups
Sponsors and collaborators
Martin Harazim
Lead sponsor
Brno University Hospital
Sponsor institution