Portal Hypertension Clinical Trial
— PSVD-IndiaOfficial title:
Clinical Diagnosis and Pathological Spectrum of Porto-sinusoidal Vascular Disease in India
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Dr. Madhumita Premkumar | Sector-12 | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Post Graduate Institute of Medical Education and Research, Chandigarh |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To describe the clinical presentation of patients with a diagnosis of PSVD. | Listing clinical presentation (signs and symptoms) of patients with PSVD (variceal bleeding, pain, ascites, sensation of lump, etc) | Day 0 | |
Secondary | Radiological description of patients with PSVD based on CT venography | Radiological assessment will be done at baseline for characterization of changes of portal vein, small hepatic veins, liver and splenic morphology. Doppler of the portal vessels. | Day 0 | |
Secondary | Radiological description of patients with PSVD based on Doppler Ultrasound | Radiological assessment will be done at baseline for characterization of changes of portal vein, small hepatic veins, liver and splenic morphology. Doppler of the portal vessels. | Day 0 | |
Secondary | Histopathological features and subtypes of the PSVD spectrum in patients from India with assessment of parenchyma, vessels, portal triad and fibrosis | To classify the PSVD based on the histological finding the disease. | Day 0 | |
Secondary | Ratio of liver stiffness and splenic stiffness using transient elastography in diagnosis of PSVD | To look for the trend of non-invasive techniques in PSVD such as ARFI, transient elastography, coagulation parameters, and inflammatory biomarkers in patients of PSVD | Day 0 | |
Secondary | Change in biomarkers like Factor VIII Ag or vWF in diagnosis of PSVD | To look for the trend of non-invasive techniques in PSVD such as coagulation parameters, and inflammatory biomarkers in patients of PSVD | Day 0 | |
Secondary | Presence of varices and other endoscopic findings in patients with PSVD | To look for esophageal varices and portal hypertensive gastropathy | Day 0 |
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