About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age range of 18-70 years
Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings.
Undergoing elective surgery or liver transplantation
Disqualifiers
• Hepatocellular carcinoma
Pregnancy or lactation
Patients with HIV or retroviral therapy
Prior liver interventions like locoregional therapy, presence of HCC, prior abdominal surgery
Trial population
Cirrhosis Healthy liver control tissue will be taken from autopsy patients with consent
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Assessment of microplastics in tissue
Diagnostic testAfter 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.
Treatment groups
Trial outcomes
Primary outcomes
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
MPs in liver cirrhosis
Secondary outcomes
• Identification of Various polymer types, including PS, PVC, PET, PMMA, POM, and PP and surface alterations indicative of long-term deposition.
Assessment 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 endoscopy
Assessment of gastric and duodenal mucosa for micronanoplastics during elective endoscopy.
Assessment of micronanoplastics in peripheral blood
Dried blood spots assessment of micronanoplastics
Other outcomes
Association of microplastics with degree of liver fibrosis and inflammation
Comparison of presence of microplastics with histopathological inflammation and presence of fibrosis grade.
Sponsors and contacts
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Post Graduate Institute of Medical Education and Research, Chandigarh
Lead sponsor
Vellore Institute of Technology University
Collaborator