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Microplastics, Cirrhosis and Portal Hypertension

The Impact of Microplastics and Nanoplastics on Liver Health and Cardiovascular Diseases in India

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07280390
Enrollment
30
Registered
2025-12-12
Start date
2026-05-01
Completion date
2027-02-25
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Cirrhosis and Chronic Liver Disease, Microplastics, Nanoplastics, Pollution, Portal Hypertension Related to Cirrhosis

Keywords

Microplastics, Nanoplastics, Plastic pollution, Cirrhosis, Portal hypertension

Brief summary

Cirrhosis and portal hypertension are associated with an hyperdynamic circulation and hepatic inflammation, leading to complications like ascites, variceal bleeding, acute kidney injury, and higher infection risk. Microplastics (MPs) are a global plastic pollution issue, and studies have found plastic MPs or nanoparticles (NPs) contaminating human, animal and environmental ecosystems.It has been noted that the accumulation of MPs increases with a reduction in size of the plastic particle. MPs are categorized into primary particles such as manufactured plastics including pellets and cosmetic microbeads and secondary particles which originate from mechanical and ultraviolet disruption of large plastic particles. MPs can be ingested via food or beverages, especially plastic packaged comestibles or inhaled as environmental pollutants. Contamination of medications such as antibiotics, intravenous fluids, albumin and medical devices is another source of exposure to microplastics in patients with chronic liver disease (CLD)In particular exposure to endoscopic interventions, liver biopsy, and invasive procedures such as paracentesis and interventional radiology procedures can lead to plastic exposure and deposition of MPs in the liver and other tissues in patients with cirrhosis. It may be hypothesized that these may contribute to hepatic inflammation and progression of cirrhosis and portal hypertension. Globally, there is new research on the influence of MPs on the environment, plant and animal ecosystems and human health. Polystyrene (PS) microspheres that concentrate in the liver, intestine and the kidneys of mammals disrupt lipid and energy metabolism, impair mucus secretion, and alter the microbiome. Therefore, studies are required to assess how and to what extent, MPs impact human health, and affect chronic diseases like cirrhosis and reduce longevity. The study investigators will assess the presence of MPs in the liver, kidneys and intestine of patients with liver cirrhosis and compare it with those without underlying liver disease and determine the impact on portal hypertension and fibrosis, and cardiovascular and metabolic function.

Detailed description

First, because the methodology requires chemical digestion, it is unclear where in the liver MPs are deposited. For instance, it is indeterminate if MPs are deposited intracellularly, in Kupffer cells, endothelium or hepatocytes/cholangiocytes. In the present study histopathological assessments of the liver tissue will be performed to determine the presence of the MPs. * Furthermore, the study will assess various polymer types of MP in cirrhotic liver tissue including commonly observed plastic polymers PS (polystyrene), PE (polyethylene), PP (polypropylene), PVC (polyvinyl chloride), PET (polyethylene terephthalate), PC (polycarbonate), and PMMA (polymethyl methacrylate). * Therefore, potential cellular sites of deposition in the liver will be assessed. If the MPs were in the systemic circulation, without any liver parenchymal residues, such particles should also be identified in spleen and kidney samples. * histopathology and electron microscopy of the liver tissue which should clarify the specific accumulation sites.

Interventions

DIAGNOSTIC_TESTAssessment of microplastics in tissue

After meeting inclusion and exclusion criteria, 30 patients with cirrhosis will be included in this study with written informed consent from patient (surgical cases) or scheduled liver biopsy. Diagnosis of chronic liver disease will be based on history, physical examination, laboratory investigations, upper gastrointestinal endoscopy as recorded in the patient file, imaging studies (ultrasonography and doppler of splenoportal venous axis). Underlying etiology of liver disease will be recorded. Complications of cirrhosis like hepatorenal syndrome (HRS), spontaneous bacterial peritonitis (SBP), upper gastrointestinal bleed, hepatic encephalopathy, acute kidney injury will be recorded from the patient's casefile. Tissue Sample Processing Standard laboratory solvents (i.e., acetonitrile, methanol, and water (LiChrosolv and SupraSolv grade) will be procured. The contact of laboratory surfaces and equipment will be minimized to reduce the risk of background contamination by plastics.

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER
Vellore Institute of Technology University
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age range of 18-70 years * Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings. * Undergoing elective surgery or liver transplantation

Exclusion criteria

* • Hepatocellular carcinoma * Pregnancy or lactation * Patients with HIV or retroviral therapy * Prior liver interventions like locoregional therapy, presence of HCC, prior abdominal surgery

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome is to assess MPs in human liver tissue, analysing their morphology, size, and composition (4-30 µm) in tissue samples from the liver inpatients with cirrhosis as compared with controls without cirrhosisAt time of enrolmentMPs in liver cirrhosis

Secondary

MeasureTime frameDescription
• Identification of Various polymer types, including PS, PVC, PET, PMMA, POM, and PP and surface alterations indicative of long-term deposition.At enrolmentAssessment of type of microparticles
• Determination of plastic pollution exposure in patients with cirrhosis by detailed history of diet, oral and parenteral medication, interventions including prior biopsy and endoscopyAt the time of elective endoscopyAssessment of gastric and duodenal mucosa for micronanoplastics during elective endoscopy.
Assessment of micronanoplastics in peripheral bloodAt enrolmentDried blood spots assessment of micronanoplastics

Countries

India

Contacts

CONTACTMadhumita Premkumar, MD DM
drmadhumitap@gmail.com01722754777
PRINCIPAL_INVESTIGATORMadhumita Premkumar

PGIMER Chandigarh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026