Portal HypertensionPSVD-IndiaNCT06054451
Clinical Diagnosis and Pathological Spectrum of Porto-sinusoidal Vascular Disease in India
An observational study of Portal Hypertension and Budd-Chiari Syndrome, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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)… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Portal Hypertension, Budd-Chiari Syndrome, Non-Cirrhotic Portal Hypertension
- How many people
- 210 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed as NCPF, EHPVO, HVOTO, SOS, VOD will be screened for reclassification based on diagnostic criteria for PSVD
Who may be able to join
- Patients of 12-70 years, either gender with clinical, pathological radiological diagnosis of NCPH
Who cannot join
- Any patients having Cirrhosis based on clinical, pathological, or radiological diagnosis
- Any patients having active malignancy
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr. Madhumita Premkumar
Sector-12, Chandigarh, 160012
Dr. Madhumita Premkumar, MD, drmadhumitap@gmail.com
About this study
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.
Read the detailed description
Portal hypertension is clinically characterized by a portal venous pressure gradient between the inferior vena cava and the portal vein is more than 5 mm. Liver cirrhosis remains the leading cause of portal hypertension in the western world. However, there are conditions where portal hypertension can even occur without liver cirrhosis, referred to as Noncirrhotic portal hypertension (NCPH). The term NCPH has been derived from a variety of histopathological entities such as hepatoportal sclerosis, noncirrhotic portal fibrosis, nodular regenerative hyperplasia, or incomplete septal fibrosis. In the absence of other causes of cirrhosis and portal venous thrombosis, the condition is termed idiopathic noncirrhotic portal hypertension. The histopathological findings of INCPH are not entirely specific to portal hypertension, similar changes can be seen in patients without portal hypertension. Therefore the term Porto-sinusoidal vascular disorder(PSVD) has been recently introduced to define a group of liver vessel disorders affecting the portal venules and sinusoids irrespective of the absence or presence of liver cirrhosis. This disease entity can have a varied clinical presentation and histological findings and has been associated with several immunological and systemic disorders.
Porto-sinusoidal vascular disease - Currently, for clinical practice, the VALDIG group has given a working definition for PSVD.
"Liver biopsy ≥20mm without cirrhosis with either 1 specific sign of portal hypertension OR 1 specific histological finding for PSVD" OR "Liver biopsy ≥20mm without cirrhosis with 1 sign not specific for portal hypertension AND 1 sign not specific for PSVD"
- Conditions
- Portal Hypertension, Budd-Chiari Syndrome, Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases, Sinusoidal Obstruction Syndrome, Veno Occlusive Disease, Hepatic
- Keywords
- Porto-sinusoidal vascular disease, Budd Chiari Syndrom, extrahepatic portal venous obstruction, Portal Hypertension, Non-Cirrhotic Portal Fibrosis
- Medical subject headings
- Hypertension, Portal, Budd-Chiari Syndrome, Idiopathic Noncirrhotic Portal Hypertension, Hepatic Veno-Occlusive Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0
Secondary outcomes (6)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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
Measured: Day 0
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
Measured: Day 0
Presence of varices and other endoscopic findings in patients with PSVD
To look for esophageal varices and portal hypertensive gastropathy
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Aug 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Dr Madhumita Premkumar, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054451
- Sponsor's protocol ID
- IEC-INT/2023/MD-1081
- Acronym
- PSVD-India
- Status last verified
- Apr 2024
- First submitted
- 11 Aug 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Diagnosis and Pathological Spectrum of Porto-sinusoidal Vascular Disease in India
- ClinicalTrials.gov ID
- NCT06054451
- Acronym / sponsor ID
- PSVD-India / IEC-INT/2023/MD-1081
- Conditions
- Portal Hypertension, Budd-Chiari Syndrome, Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases, Sinusoidal Obstruction Syndrome, Veno Occlusive Disease, Hepatic
- Keywords
- Porto-sinusoidal vascular disease, Budd Chiari Syndrom, extrahepatic portal venous obstruction, Portal Hypertension, Non-Cirrhotic Portal Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Portal hypertension is clinically characterized by a portal venous pressure gradient between the inferior vena cava and the portal vein is more than 5 mm. Liver cirrhosis remains the leading cause of portal hypertension in the western world. However, there are conditions where portal hypertension can even occur without liver cirrhosis, referred to as Noncirrhotic portal hypertension (NCPH). The term NCPH has been derived from a variety of histopathological entities such as hepatoportal sclerosis, noncirrhotic portal fibrosis, nodular regenerative hyperplasia, or incomplete septal fibrosis. In the absence of other causes of cirrhosis and portal venous thrombosis, the condition is termed idiopathic noncirrhotic portal hypertension. The histopathological findings of INCPH are not entirely specific to portal hypertension, similar changes can be seen in patients without portal hypertension. Therefore the term Porto-sinusoidal vascular disorder(PSVD) has been recently introduced to define a group of liver vessel disorders affecting the portal venules and sinusoids irrespective of the absence or presence of liver cirrhosis. This disease entity can have a varied clinical presentation and histological findings and has been associated with several immunological and systemic disorders.
Porto-sinusoidal vascular disease - Currently, for clinical practice, the VALDIG group has given a working definition for PSVD.
"Liver biopsy ≥20mm without cirrhosis with either 1 specific sign of portal hypertension OR 1 specific histological finding for PSVD" OR "Liver biopsy ≥20mm without cirrhosis with 1 sign not specific for portal hypertension AND 1 sign not specific for PSVD"
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed as NCPF, EHPVO, HVOTO, SOS, VOD will be screened for reclassification based on diagnostic criteria for PSVD
Key inclusion criteria (1 listed)
- Patients of 12-70 years, either gender with clinical, pathological radiological diagnosis of NCPH
Key exclusion criteria (2 listed)
- Any patients having Cirrhosis based on clinical, pathological, or radiological diagnosis
- Any patients having active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the clinical presentation of patients with a diagnosis of PSVD.
Time frame: Day 0
Listing clinical presentation (signs and symptoms) of patients with PSVD (variceal bleeding, pain, ascites, sensation of lump, etc)
6 secondary outcomes
Radiological description of patients with PSVD based on CT venography
Time frame: Day 0
Radiological description of patients with PSVD based on Doppler Ultrasound
Time frame: Day 0
Histopathological features and subtypes of the PSVD spectrum in patients from India with assessment of parenchyma, vessels, portal triad and fibrosis
Time frame: Day 0
Ratio of liver stiffness and splenic stiffness using transient elastography in diagnosis of PSVD
Time frame: Day 0
Change in biomarkers like Factor VIII Ag or vWF in diagnosis of PSVD
Time frame: Day 0
Presence of varices and other endoscopic findings in patients with PSVD
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Madhumita Premkumar, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Budd-Chiari Syndrome, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Madhumita Premkumar, DM (7087003409, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the clinical presentation of patients with a diagnosis of PSVD. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.