Microplastics in Pancreas: Oncologic and Metabolic Impact

NCT07486128 | Not Yet Recruiting

• 1 other identifier: 27066
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Diseases; Pancreatic Neoplasms

Keywords

Microplastics; Pancreatic Diseases; Pancreatic Neoplasms; Glucose Metabolism; Raman Spectroscopy; Pancreatic Tissue

Outcome Measures

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.

  At time of surgery

Secondary Outcomes (3)

• Association Between Microplastic Burden and Metabolic Function

  Preoperative assessment

• Distribution of Microplastics Across Biological Compartments

  At time of surgery

• Characterization of Microplastic Particles

  At time of analysis

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Pancreatic Diseases; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Central Study Contacts

Sergio Alfieri, MD

CONTACT

+390530155133; sergio.alfieri@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)