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

Официальное название

Study on Clinicopathological Features, Influencing Factors and Clinical Outcomes in Patients With Porto-sinusoidal Vascular Disease (PSVD)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Transplant-free survival [Срок оценки: 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.]

Вторичные конечные точки (1)

• Liver-related composite events [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Ditan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07744048 · DTEC-KY2026-099-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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