Unveiling Microplastics in Human Pancreatic Tissue - Oncological and Metabolical Implications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Presence of Microplastics in Human Pancreatic Tissue
研究概览
简要总结
Microplastics and nanoplastics (MNPs) are emerging environmental contaminants that have been detected in several human tissues, raising concerns about their potential impact on human health. However, their presence in the human pancreas has not yet been investigated.
The aim of this prospective, single-center study is to detect and characterize microplastics in human pancreatic tissue obtained from patients undergoing pancreatic resection for benign or malignant diseases. Microplastics will also be analyzed in peripancreatic adipose tissue and peripheral blood. Advanced imaging techniques, including fluorescence microscopy, confocal microscopy, and Raman spectroscopy, will be used for identification and characterization.
Secondary objectives include the evaluation of potential associations between microplastic burden and pancreatic metabolic function, assessed through clinical evaluation and metabolic testing. This proof-of-concept study aims to provide the first evidence of microplastic presence in the human pancreas and explore their potential role in metabolic dysfunction and carcinogenesis.
详细描述
Microplastics and nanoplastics (MNPs) are increasingly recognized as widespread environmental contaminants with potential implications for human health. Recent evidence has demonstrated their presence in several human tissues, including lungs, placenta, cardiovascular system, and blood. However, the presence and potential role of microplastics in the human pancreas have not yet been investigated.
Preclinical studies suggest that MNP accumulation may impair pancreatic endocrine and exocrine function and contribute to carcinogenesis through mechanisms involving oxidative stress, inflammation, and cellular damage. Understanding whether microplastics accumulate in pancreatic tissue and their possible biological effects may provide new insights into pancreatic diseases, including metabolic disorders and cancer.
The PAN-Plastic study is a prospective, single-center, proof-of-concept study conducted at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The primary objective is to detect and characterize microplastics in human pancreatic tissue obtained from patients undergoing pancreatic resection for benign or malignant conditions.
Biological samples will include pancreatic tissue (both non-neoplastic and peri-neoplastic), peripancreatic adipose tissue, and peripheral blood. To minimize contamination, all samples will be collected, processed, and stored using non-plastic materials and standardized procedures.
Microplastics will be identified and characterized using a multimodal approach, including fluorescence microscopy, confocal microscopy for three-dimensional localization, and Raman spectroscopy for chemical characterization of polymer composition. This combined methodology allows for accurate detection, quantification, and classification of microplastic particles within biological tissues.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years Patients scheduled for elective pancreatic resection for benign or malignant pancreatic disease Ability to understand and provide written informed consent No contraindications to general anesthesia
排除标准
- •Age <18 or >80 years Severe hepatic insufficiency (Child-Pugh class C) Pregnancy or breastfeeding Inability to understand the study procedures or provide informed consent
结局指标
主要结局
Presence of Microplastics in Human Pancreatic Tissue
时间窗: At time of surgery
Detection and quantification of microplastics in human pancreatic tissue samples (non-neoplastic and peri-neoplastic), peripancreatic adipose tissue, and peripheral blood using fluorescence microscopy, confocal microscopy, and Raman spectroscopy. Microplastic burden will be expressed as number of particles per gram of tissue or per mL of blood.
次要结局
- Association Between Microplastic Burden and Metabolic Function(Preoperative assessment)
- Distribution of Microplastics Across Biological Compartments(At time of surgery)
- Characterization of Microplastic Particles(At time of analysis)
研究者
ALFIERI SERGIO
Professor of Surgery
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
