Microplastics in Pancreas: Oncologic and Metabolic Impact
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population consists of adult patients undergoing elective pancreatic resection for benign or malignant pancreatic diseases at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, a tertiary referral center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10 Participants
are grouped into 1 trial groupGroup A: Patients Undergoing Pancreatic Resection
Trial outcomes
Primary outcomes
1
Presence of Microplastics in Human Pancreatic Tissue
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
At time of surgerySecondary outcomes
1
Association Between Microplastic Burden and Metabolic Function
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
Preoperative assessment2
Distribution of Microplastics Across Biological Compartments
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 surgery3
Characterization of Microplastic Particles
Chemical and morphological characterization of detected microplastics, including polymer type and particle size, using Raman spectroscopy and imaging techniques.
Time frame
At time of analysisSponsors and contacts
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Source ClinicalTrials.gov
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