Understanding Porto-sinusoidal Vascular Disease in India
Clinical Diagnosis and Pathological Spectrum of Porto-sinusoidal Vascular Disease in India
This study is trying to see if a new way to classify a liver condition called Porto-sinusoidal Vascular Disease can help better understand and diagnose patients in India who have Non-Cirrhotic Portal Hypertension.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 12 Years to 70 Years |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Sector-12, Chandigarh) |
| Trial ID | NCT06054451 on ClinicalTrials.gov |
What this trial studies
This observational study aims to re-evaluate patients diagnosed with Non-Cirrhotic Portal Hypertension (NCPH) in India and determine the applicability of a new histological classification for Porto-sinusoidal Vascular Disease (PSVD). It will involve screening patients based on liver biopsy, endoscopy, and radiology reports to identify those fitting the PSVD diagnosis. The study will compare cohorts diagnosed with INCPH against those meeting the new PSVD criteria, while also assessing demographic, clinical, and etiological factors. The goal is to establish the relevance of PSVD in the Indian population and the utility of invasive diagnostic tests.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12-70 years, of any gender, with a clinical, pathological, or radiological diagnosis of Non-Cirrhotic Portal Hypertension.
Not a fit: Patients with cirrhosis or active malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and treatment strategies for patients with portal hypertension and related conditions.
How similar studies have performed: While the approach of re-evaluating diagnostic criteria is not novel, the specific focus on the Indian population and the application of the VALDIG classification is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of 12-70 years, either gender with clinical, pathological radiological diagnosis of NCPH Exclusion Criteria: * Any patients having Cirrhosis based on clinical, pathological, or radiological diagnosis * Any patients having active malignancy
Where this trial is running
Sector-12, Chandigarh
- Dr. Madhumita Premkumar — Sector-12, Chandigarh, India (Recruiting)
Study contacts
- Principal investigator: Dr Madhumita Premkumar, DM — Pgimer
- Study coordinator: Dr Madhumita Premkumar, DM
- Email: drmadhumitap@gmail.com
- Phone: 7087003409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.