Study on Clinicopathological Features, Influencing Factors and Clinical Outcomes in Patients With Porto-sinusoidal Vascular Disease (PSVD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Transplant-free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Transplant-free survival
时间窗: 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.
次要结局
- 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.)
研究者
Minghui Li
Head of Department
Beijing Municipal Administration of Hospitals