Porto-Sinusoidal Vascular DiseasesNCT07744048
Study on Clinicopathological Features, Influencing Factors and Clinical Outcomes in Patients With PSVD
An observational study of Porto-Sinusoidal Vascular Diseases, run by Beijing Municipal Administration of Hospitals at 1 site in China.
Trial summary
This retrospective-prospective cohort study investigates portal sinusoidal vascular disorder (PSVD), a liver vascular disease definitively diagnosed via liver biopsy. Addressing PSVD's poorly defined natural history, unclear prognostic determinants and the scarcity of large-scale systematic research in China, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Porto-Sinusoidal Vascular Diseases
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adult patients aged 18 years and older with histopathologically confirmed porto-sinusoidal vascular disease (PSVD) via liver biopsy and no histological evidence of cirrhosis. All subjects are inpatients and outpatients from Beijing Ditan Hospital, covering subgroups with or without portal vein thrombosis, portal hypertension, known etiologies or concurrent chronic liver diseases. Patients with Budd-Chiari syndrome, hepatic venous outflow obstruction, congenital hepatic fibrosis, sinusoidal obstruction syndrome, hepatic malignancies or severely incomplete clinical data are excluded.
Who may be able to join
- Patients histopathologically diagnosed with porto-sinusoidal vascular disorder (PSVD) via liver needle biopsy;
- Liver biopsy specimen length ≥ 10 mm (or assessed as diagnostically adequate by a pathologist), with no histological evidence of cirrhosis;
- Meeting the established diagnostic criteria for PSVD.
Who cannot join
- Concomitant Budd-Chiari syndrome or other hepatic venous outflow obstruction diseases;
- Concomitant congenital hepatic fibrosis, hepatic sarcoidosis, or sinusoidal obstruction syndrome;
- Concomitant hepatocellular carcinoma or other hepatic malignancies;
- Age < 18 years;
- Severe deficiency of clinical data that precludes valid analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
About this study
Official title: Study on Clinicopathological Features, Influencing Factors and Clinical Outcomes in Patients With Porto-sinusoidal Vascular Disease (PSVD)
This retrospective-prospective cohort study investigates portal sinusoidal vascular disorder (PSVD), a liver vascular disease definitively diagnosed via liver biopsy. Addressing PSVD's poorly defined natural history, unclear prognostic determinants and the scarcity of large-scale systematic research in China, the study enrolls histopathologically confirmed patients, collects baseline clinicopathological, laboratory and imaging data, tracks endpoints including transplant-free survival, liver-related events and portal vein thrombosis changes, and conducts prognostic analyses using Cox regression, Kaplan-Meier method and Fine-Gray model, aiming to characterize disease features, identify key prognostic factors, verify high-risk subgroups with inferior outcomes, and support precise clinical management while filling relevant domestic research gaps.
Read the detailed description
The study aims to include approximately 100-150 patients with histopathologically confirmed PSVD by liver biopsy, covering subgroups with/without definite etiology, with/without PVT, with/without portal hypertension, etc. Collect demographic, clinical, laboratory, imaging and pathological data of enrolled patients. Follow up endpoints including transplant-free survival, liver-related events and dynamic changes of PVT. Apply Cox regression, Kaplan-Meier method and Fine-Gray model to identify independent prognostic factors and compare prognosis differences among subgroups, so as to provide reference for clinical diagnosis and treatment of PSVD.
- Conditions
- Porto-Sinusoidal Vascular Diseases
- Keywords
- Porto-sinusoidal vascular disorder, PSVD, INCPH
- Medical subject headings
- Idiopathic Noncirrhotic Portal Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-free survival
Time from study enrollment to all-cause death or liver transplantation, whichever occurs first.
Measured: From baseline through Month 36, with outcome status assessed at Months 6, 12, 18, 24, 30, and 36, or until all-cause death or liver transplantation, whichever occurs first.
Secondary outcomes (1)
Liver-related composite events
Occurrence of variceal bleeding, refractory ascites, hepatic encephalopathy, PVT progression or hepatic decompensation.
Measured: From baseline through Month 36, with outcome status assessed at Months 6, 12, 18, 24, 30, and 36, or until all-cause death or liver transplantation, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Porto-Sinusoidal Vascular DiseasesStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Minghui Li, Beijing Municipal Administration of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744048
- Sponsor's protocol ID
- DTEC-KY2026-099-01
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Clinicopathological Features, Influencing Factors and Clinical Outcomes in Patients With Porto-sinusoidal Vascular Disease (PSVD)
- ClinicalTrials.gov ID
- NCT07744048
- Acronym / sponsor ID
- DTEC-KY2026-099-01
- Conditions
- Porto-Sinusoidal Vascular Diseases
- Keywords
- Porto-sinusoidal vascular disorder, PSVD, INCPH
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 4 Aug 2026 (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.
This retrospective-prospective cohort study investigates portal sinusoidal vascular disorder (PSVD), a liver vascular disease definitively diagnosed via liver biopsy. Addressing PSVD's poorly defined natural history, unclear prognostic determinants and the scarcity of large-scale systematic research in China, the study enrolls histopathologically confirmed patients, collects baseline clinicopathological, laboratory and imaging data, tracks endpoints including transplant-free survival, liver-related events and portal vein thrombosis changes, and conducts prognostic analyses using Cox regression, Kaplan-Meier method and Fine-Gray model, aiming to characterize disease features, identify key prognostic factors, verify high-risk subgroups with inferior outcomes, and support precise clinical management while filling relevant domestic research gaps.
Detailed description
The study aims to include approximately 100-150 patients with histopathologically confirmed PSVD by liver biopsy, covering subgroups with/without definite etiology, with/without PVT, with/without portal hypertension, etc. Collect demographic, clinical, laboratory, imaging and pathological data of enrolled patients. Follow up endpoints including transplant-free survival, liver-related events and dynamic changes of PVT. Apply Cox regression, Kaplan-Meier method and Fine-Gray model to identify independent prognostic factors and compare prognosis differences among subgroups, so as to provide reference for clinical diagnosis and treatment of PSVD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients aged 18 years and older with histopathologically confirmed porto-sinusoidal vascular disease (PSVD) via liver biopsy and no histological evidence of cirrhosis. All subjects are inpatients and outpatients from Beijing Ditan Hospital, covering subgroups with or without portal vein thrombosis, portal hypertension, known etiologies or concurrent chronic liver diseases. Patients with Budd-Chiari syndrome, hepatic venous outflow obstruction, congenital hepatic fibrosis, sinusoidal obstruction syndrome, hepatic malignancies or severely incomplete clinical data are excluded.
Key inclusion criteria (3 listed)
- Patients histopathologically diagnosed with porto-sinusoidal vascular disorder (PSVD) via liver needle biopsy;
- Liver biopsy specimen length ≥ 10 mm (or assessed as diagnostically adequate by a pathologist), with no histological evidence of cirrhosis;
- Meeting the established diagnostic criteria for PSVD.
Key exclusion criteria (5 listed)
- Concomitant Budd-Chiari syndrome or other hepatic venous outflow obstruction diseases;
- Concomitant congenital hepatic fibrosis, hepatic sarcoidosis, or sinusoidal obstruction syndrome;
- Concomitant hepatocellular carcinoma or other hepatic malignancies;
- Age < 18 years;
- Severe deficiency of clinical data that precludes valid analysis.
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
Transplant-free survival
Time frame: From baseline through Month 36, with outcome status assessed at Months 6, 12, 18, 24, 30, and 36, or until all-cause death or liver transplantation, whichever occurs first.
Time from study enrollment to all-cause death or liver transplantation, whichever occurs first.
1 secondary outcome
Liver-related composite events
Time frame: From baseline through Month 36, with outcome status assessed at Months 6, 12, 18, 24, 30, and 36, or until all-cause death or liver transplantation, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Porto-Sinusoidal Vascular Diseases
Not yet recruiting
Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder
Porto-sinusoidal Vascular Liver Disorder, Liver Cirrhosis
RecruitingObservational study
TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
TIPS, Portal Hypertension
RecruitingObservational study
Non-invasive Tools for PSVD Diagnosis
Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases
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.
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 Porto-Sinusoidal Vascular Diseases, run by Beijing Municipal Administration of Hospitals at 1 site in China.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Aug 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghui Li, Dr (+8613693259096, wuhm2000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-free survival (time frame: From baseline through Month 36, with outcome status assessed at Months 6, 12, 18, 24, 30, and 36, or until all-cause death or liver transplantation, whichever occurs first.). 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 4 Aug 2026.