Feasibility, Safety and Clinical Impact of Bedside Microenvironmental Monitoring in Infected Walled-Off Pancreatic Necrosis During Standard Percutaneous Drainage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility and Safety of Intracavitary Monitoring During Percutaneous Drainage of Infected WOPN
研究概览
简要总结
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.
详细描述
Background:
Infected walled-off pancreatic necrosis (WOPN) represents a critical complication of acute necrotizing pancreatitis. Management typically includes antibiotics and step-up interventional drainage. However, decision-making is often based on indirect systemic markers, and very little is known about the actual in situ microenvironmental conditions (e.g., pH, oxygenation, redox status) inside the necrotic cavity.
Rationale and Innovation:
The metabolic and microbiological activity within infected WOPN likely alters the local chemical environment, particularly in terms of acidity and anaerobic conditions. These changes may influence pathogen virulence, host immune response, and - importantly - the stability and efficacy of administered antibiotics. There is currently no standard method for directly monitoring these local parameters at the bedside. This pilot study explores the feasibility and potential clinical value of such monitoring.
Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Feasibility and Safety of Intracavitary Monitoring During Percutaneous Drainage of Infected WOPN
时间窗: From Day 0 (drainage procedure) to Day 3 or removal of the probe, whichever occurs first
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.
次要结局
未报告次要终点
研究者
Martin Harazim
Principal Investigator, Department of Gastroenterology and Intensive Care Medicine
Brno University Hospital