Bedside Monitoring of Microenvironmental Changes in Infected Pancreatic Collections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMartin Harazim
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Miniaturized Intracavitary Monitoring Probe
DeviceA sterile, miniaturized, biocompatible monitoring probe (≤1.5 mm diameter) is temporarily introduced into the cavity of an infected walled-off pancreatic necrosis (WOPN) during standard percutaneous drainage. The device is designed to measure local microenvironmental parameters in situ, such as acidity and related indicators, without interfering with fluid evacuation. Measurements are performed intermittently or continuously for up to 72 hours and are used solely for observational purposes. This intervention is distinct from standard WOPN management, as it allows real-time assessment of local physicochemical conditions, which are not accessible through systemic biomarkers or imaging alone.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Bedside Microenvironment Monitoring ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility and Safety of Intracavitary Monitoring During Percutaneous Drainage of Infected WOPN
Successful placement, function, and removal of the miniaturized monitoring probe during standard percutaneous drainage of infected WOPN. Feasibility is defined as the ability to insert the probe without interrupting drainage, record interpretable data for at least 24 hours, and remove the device without adverse events. Safety is assessed by the absence of procedure-related complications, such as bleeding, infection exacerbation, or drainage dysfunction related to the monitoring device.
Time frame
From Day 0 (drainage procedure) to Day 3 or removal of the probe, whichever occurs firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Martin Harazim
Lead sponsor
Brno University Hospital
Sponsor institution
Source ClinicalTrials.gov
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