ClinicalTrials.gg
Not yet recruitingNCT07744048Updated Aug 4, 2026

Study on Clinicopathological Features, Influencing Factors and Clinical Outcomes in Patients With PSVD

An observational study in Porto-Sinusoidal Vascular Diseases, sponsored by Beijing Municipal Administration of Hospitals. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Beijing Municipal Administration of Hospitals · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Porto-Sinusoidal Vascular Diseases

Keywords

  • Porto-sinusoidal vascular disorder
  • PSVD
  • INCPH
03

In context

Lead sponsor

Beijing Municipal Administration of Hospitals is the lead sponsor of 14 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients histopathologically diagnosed with porto-sinusoidal vascular disorder (PSVD) via liver needle ;
  2. Liver biopsy specimen length ≥ 10 mm (or assessed as diagnostically adequate by a pathologist), with no histological evidence of cirrhosis;
  3. Meeting the established diagnostic criteria for PSVD.

Exclusion criteria

Exclusion Criteria:

  1. Concomitant Budd-Chiari syndrome or other hepatic venous outflow obstruction diseases;
  2. Concomitant congenital hepatic fibrosis, hepatic sarcoidosis, or sinusoidal obstruction syndrome;
  3. Concomitant hepatocellular carcinoma or other hepatic ;
  4. Age \< 18 years;
  5. Severe deficiency of clinical data that precludes valid analysis.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
150 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Transplant-free survival

    Time from study enrollment to all-cause death or liver transplantation, whichever occurs first.

    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.

Secondary outcomes

  1. Liver-related composite events

    Occurrence of variceal bleeding, refractory ascites, hepatic encephalopathy, PVT progression or hepatic decompensation.

    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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Jul 2028, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2026
First posted
Aug 4, 2026
StartEst.
Aug 1, 2026
Primary completionEst.
Jul 30, 2028
CompletionEst.
Jul 30, 2028
Last update
Aug 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07744048
Lead sponsor
Beijing Municipal Administration of Hospitals
Responsible party
Minghui Li (Head of Department, Beijing Municipal Administration of Hospitals) — Principal investigator
First posted
Aug 4, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Jul 30, 2028 (estimated)
Completion
Jul 30, 2028 (estimated)
Last update
Aug 4, 2026

Study contacts

Minghui Li, Dr
Contact
wuhm2000@sina.com
+8613693259096
Weihua Cao, Dr
Contact
weihuacaohappy@163.com
+8618811333139

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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