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NOT YET RECRUITING
NCT07131917
NA

Bedside Monitoring of Microenvironmental Changes in Infected Pancreatic Collections

Sponsor: Martin Harazim

View on ClinicalTrials.gov

Summary

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.

Official title: Feasibility, Safety and Clinical Impact of Bedside Microenvironmental Monitoring in Infected Walled-Off Pancreatic Necrosis During Standard Percutaneous Drainage

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-11-01

Completion Date

2026-06-15

Last Updated

2025-08-20

Healthy Volunteers

No

Interventions

DEVICE

Miniaturized Intracavitary Monitoring Probe

A 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.

Locations (1)

University Hospital Brno

Brno, Czechia