Pancreatic DiseasesPAN-PlasticNCT07486128
Microplastics in Pancreas: Oncologic and Metabolic Impact
An observational study of Pancreatic Diseases and Pancreatic Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Diseases, Pancreatic Neoplasms
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2026to 1 Apr 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma
Rome, Lazio, 00168
About this study
Official title: 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.
Read the 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
- Keywords
- Microplastics, Pancreatic Diseases, Pancreatic Neoplasms, Glucose Metabolism, Raman Spectroscopy, Pancreatic Tissue
- Medical subject headings
- Pancreatic Diseases, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of surgery
Secondary outcomes (3)
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).
Measured: Preoperative assessment
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.
Measured: At time of surgery
Characterization of Microplastic Particles
Chemical and morphological characterization of detected microplastics, including polymer type and particle size, using Raman spectroscopy and imaging techniques.
Measured: At time of analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALFIERI SERGIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486128
- Sponsor's protocol ID
- 27066
- Acronym
- PAN-Plastic
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unveiling Microplastics in Human Pancreatic Tissue - Oncological and Metabolical Implications
- ClinicalTrials.gov ID
- NCT07486128
- Acronym / sponsor ID
- PAN-Plastic / 27066
- Conditions
- Pancreatic Diseases, Pancreatic Neoplasms
- Keywords
- Microplastics, Pancreatic Diseases, Pancreatic Neoplasms, Glucose Metabolism, Raman Spectroscopy, Pancreatic Tissue
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of Microplastics in Human Pancreatic Tissue
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.
3 secondary outcomes
Association Between Microplastic Burden and Metabolic Function
Time frame: Preoperative assessment
Distribution of Microplastics Across Biological Compartments
Time frame: At time of surgery
Characterization of Microplastic Particles
Time frame: At time of analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Diseases and Pancreatic Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergio Alfieri, MD (+390530155133, sergio.alfieri@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Microplastics in Human Pancreatic Tissue (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.