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Clinical Diagnosis and Pathological Spectrum of Porto-sinusoidal Vascular Disease in India

NCT06054451 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2024-04-25

No results posted yet for this study

Summary

There is a need to re-evaluate the patients classified as NCPH and determine whether the new histological classification proposed by the VALDIG applies to the Indian scenario. We intend to identify the patient cohorts who have been diagnosed as NCPH, NCPF, EHPVO, hepatic venous outlet tract obstruction (HVOTO), Veno-occlusive disease (VOD) and sinusoidal obstruction syndrome (SOS) based on their liver biopsy, endoscopy, HVPG, and radiology reports. These patients will be screened to find the patients who fit the diagnosis of PSVD. It is important to establish whether the new definition of PSVD is relevant to the Indian population and establish the usefulness of invasive tests like liver biopsy in diagnosing the disease. The patient cohorts meeting diagnosis of INCPH will be compared with those meeting the new diagnosis of PSVD. The investigators will describe the clinical (demographic, clinical risk factors, socioeconomic status), etiological (associated conditions, coagulation disorders medication use, genetic risk factors), imaging (based on ultrasound Doppler imaging or cross- sectional imaging), endoscopic, fibrosis tests (using non-invasive tests), and the histopathology of the patients who fulfil the criteria of PSVD.

Conditions

  • Portal Hypertension
  • Budd-Chiari Syndrome
  • Non-Cirrhotic Portal Hypertension
  • Porto-Sinusoidal Vascular Diseases
  • Sinusoidal Obstruction Syndrome
  • Veno Occlusive Disease, Hepatic
  • Non-Cirrhotic Portal Fibrosis

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Dr Madhumita Premkumar, DM · Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054451 on ClinicalTrials.gov