Microplastics, Cirrhosis and Portal Hypertension

NCT07280390 | Not Yet Recruiting

• 1 other identifier: PGI/IEC/2025/EIC000779
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. In the proposed study we 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.

Conditions

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

Keywords

Microplastics; Nanoplastics; Plastic pollution; Cirrhosis; Portal hypertension

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to assess MPs in human liver tissue, analysing their morphology, size, and composition (4-30 µm). We will examine tissue samples from the liver inpatients with cirrhosis as compared with controls without cirrhosis

  MPs in liver cirrhosis

  At time of enrolment

Secondary Outcomes (3)

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

  At enrolment

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

  At the time of elective endoscopy

• Assessment of micronanoplastics in peripheral blood

  At enrolment

Other Outcomes (1)

• Association of microplastics with degree of liver fibrosis and inflammation

  At enrolment

Study Arms (1)

Patients with Cirrhosis

Cirrhosis and Portal Hypertension who are getting elective surgery or liver transplantation

Diagnostic Test: Assessment of microplastics in tissue

Interventions

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.

Patients with Cirrhosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhosis Healthy liver control tissue will be taken from autopsy patients with consent

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Vellore Institute of Technology University: collaborator

Study Sites (1)

PGIMER Chandigarh

Chandigarh, Chandigarh, 160012, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Liver Biopsy tissue

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Madhumita Premkumar

  PGIMER Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madhumita Premkumar, MD DM

CONTACT

01722754777; drmadhumitap@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor of Hepatology

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 25, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

IN (1)