NCT07486128

Microplastics in Pancreas: Oncologic and Metabolic Impact

Unveiling Microplastics in Human Pancreatic Tissue - Oncological and Metabolical Implications

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Diseases
• Pancreatic Neoplasms

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-03-20
• Last updated: 2026-03-27

Locations

1 site across 1 country: Italy