Microplastics in Pancreas: Oncologic and Metabolic Impact (PAN-Plastic)
Unveiling Microplastics in Human Pancreatic Tissue - Oncological and Metabolical Implications
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sergio Alfieri, MD
- Phone Number: +390530155133
- Email: sergio.alfieri@policlinicogemelli.it
Study Locations
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Lazio
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Rome, Lazio, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients Undergoing Pancreatic Resection
Patients undergoing elective pancreatic resection for benign or malignant pancreatic diseases at a single tertiary referral center.
Biological samples, including pancreatic tissue (non-neoplastic and peri-neoplastic), peripancreatic adipose tissue, and peripheral blood, will be collected and analyzed to detect and characterize microplastics.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Presence of Microplastics in Human Pancreatic Tissue
Time Frame: At time of surgery
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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.
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At time of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Association Between Microplastic Burden and Metabolic Function
Time Frame: Preoperative assessment
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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).
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Preoperative assessment
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Distribution of Microplastics Across Biological Compartments
Time Frame: At time of surgery
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Comparison of microplastic concentration and distribution between non-neoplastic pancreatic tissue, peri-neoplastic tissue, peripancreatic adipose tissue, and peripheral blood.
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At time of surgery
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Characterization of Microplastic Particles
Time Frame: At time of analysis
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Chemical and morphological characterization of detected microplastics, including polymer type and particle size, using Raman spectroscopy and imaging techniques.
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At time of analysis
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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