Bedside Monitoring of Microenvironmental Changes in Infected Pancreatic Collections

NCT07131917 | Not Yet Recruiting

• 1 other identifier: WOPN-MONITOR-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatitis; Walled Off Pancreatic Necrosis

Keywords

pancreatitis

Outcome Measures

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.

  From Day 0 (drainage procedure) to Day 3 or removal of the probe, whichever occurs first

Study Arms (1)

Bedside Microenvironment Monitoring Arm

EXPERIMENTAL

Participants in this arm will undergo standard percutaneous drainage of infected walled-off pancreatic necrosis (WOPN) as per clinical indication. In addition, a sterile, biocompatible micro-monitoring probe will be temporarily introduced into the collection to measure local microenvironmental parameters. Measurements will be performed intermittently or continuously for up to 72 hours without compromising drainage function. No investigational drug or therapeutic intervention is administered.

Device: Miniaturized Intracavitary Monitoring Probe

Interventions

Miniaturized Intracavitary Monitoring Probe DEVICE

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.

Bedside Microenvironment Monitoring Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to provide informed consent (or surrogate consent where applicable)

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin Harazim: lead

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Martin Harazim, MD

CONTACT

+420 532 233 052; igek-jip@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Gastroenterology and Intensive Care Medicine

Model Details: All enrolled participants undergo standard percutaneous drainage of infected WOPN. A single-arm study assesses feasibility and clinical impact of adding bedside microenvironmental monitoring using a miniaturized sensor probe temporarily inserted into the collection.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

CZ (1)