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

NCT07744048 | Not Yet Recruiting

• 1 other identifier: DTEC-KY2026-099-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Porto-Sinusoidal Vascular Diseases

Keywords

Porto-sinusoidal vascular disorder; PSVD; INCPH

Outcome Measures

Primary Outcomes (1)

• Transplant-free survival

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

  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

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Municipal Administration of Hospitals: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

Idiopathic Noncirrhotic Portal Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Portal; Liver Diseases; Digestive System Diseases

Central Study Contacts

Minghui Li, Dr

CONTACT

+8613693259096; wuhm2000@sina.com

Weihua Cao, Dr

CONTACT

+8618811333139; weihuacaohappy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)