Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma
Rome, Lazio, 00168, Italy
NCT Number: NCT07486128
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Rome, Lazio, 00168, Italy
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.
Secondary objectives include the evaluation of potential associations between microplastic burden and pancreatic metabolic function. Participants will undergo metabolic assessment, including clinical evaluation, laboratory testing, fecal elastase measurement, and oral glucose tolerance testing (OGTT) with insulin secretion modeling. Metabolic phenotypes will be classified and analyzed in relation to microplastic distribution across different biological compartments.
The study is designed as an exploratory investigation with an expected enrollment of at least 10 patients over a 12-month period. Data analysis will be primarily descriptive and aimed at identifying potential correlations and generating hypotheses for future larger-scale, multicenter studies.
This study aims to provide the first evidence of microplastic presence in human pancreatic tissue and to explore their potential role in metabolic dysfunction and pancreatic carcinogenesis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
Time frame: 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.
Time frame: Preoperative assessment
Evaluation of the relationship between microplastic concentration in biological samples and metabolic parameters, including glucose levels, insulin secretion, C-peptide levels, and insulin sensitivity indices derived from oral glucose tolerance testing (OGTT).
Time frame: At time of surgery
Comparison of microplastic concentration and distribution between non-neoplastic pancreatic tissue, peri-neoplastic tissue, peripancreatic adipose tissue, and peripheral blood.
Time frame: At time of analysis
Chemical and morphological characterization of detected microplastics, including polymer type and particle size, using Raman spectroscopy and imaging techniques.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Unveiling Microplastics in Human Pancreatic Tissue - Oncological and Metabolical Implications
Acronym: PAN-Plastic
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