Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07280390

Microplastics, Cirrhosis and Portal Hypertension

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Madhumita Premkumar, Chandigarh, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of microplastics in tissue

Diagnostic Test

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.

Primary outcomes

  1. 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 cirrhosis

    Time frame: At time of enrolment

    MPs in liver cirrhosis

Secondary outcomes

  1. • Identification of Various polymer types, including PS, PVC, PET, PMMA, POM, and PP and surface alterations indicative of long-term deposition.

    Time frame: At enrolment

    Assessment of type of microparticles

  2. • Determination of plastic pollution exposure in patients with cirrhosis by detailed history of diet, oral and parenteral medication, interventions including prior biopsy and endoscopy

    Time frame: At the time of elective endoscopy

    Assessment of gastric and duodenal mucosa for micronanoplastics during elective endoscopy.

  3. Assessment of micronanoplastics in peripheral blood

    Time frame: At enrolment

    Dried blood spots assessment of micronanoplastics

Other outcomes

  1. Association of microplastics with degree of liver fibrosis and inflammation

    Time frame: At enrolment

    Comparison of presence of microplastics with histopathological inflammation and presence of fibrosis grade.

Study contacts

Contact information is provided by the study sponsor or research team.

Madhumita Premkumar, MD DM

CONTACT

[email protected]

01722754777

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Collaborators

  • Vellore Institute of Technology University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.