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

NCT06054451 | Recruiting

• 1 other identifier: IEC-INT/2023/MD-1081
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Porto-sinusoidal vascular disease; Budd Chiari Syndrom; extrahepatic portal venous obstruction; Portal Hypertension; Non-Cirrhotic Portal Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Radiological description of patients with PSVD based on CT venography

  Day 0

• Radiological description of patients with PSVD based on Doppler Ultrasound

  Day 0

• Histopathological features and subtypes of the PSVD spectrum in patients from India with assessment of parenchyma, vessels, portal triad and fibrosis

  Day 0

• Ratio of liver stiffness and splenic stiffness using transient elastography in diagnosis of PSVD

  Day 0

• Change in biomarkers like Factor VIII Ag or vWF in diagnosis of PSVD

  Day 0

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed as NCPF, EHPVO, HVOTO, SOS, VOD will be screened for reclassification based on diagnostic criteria for PSVD

You may qualify if:

• Patients of 12-70 years, either gender with clinical, pathological radiological diagnosis of NCPH

You may not qualify if:

• Any patients having Cirrhosis based on clinical, pathological, or radiological diagnosis
• Any patients having active malignancy

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dr. Madhumita Premkumar

Sector-12, Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal; Budd-Chiari Syndrome; Idiopathic Noncirrhotic Portal Hypertension; Hepatic Veno-Occlusive Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr Madhumita Premkumar, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Madhumita Premkumar, DM

CONTACT

7087003409; drmadhumitap@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: September 26, 2023
• Study Start: August 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)