Observational Study
Conditions
Brief summary
The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at collecting clinical data, patient reported outcomes and biological samples of all patients who have been newly and previously diagnosed with liver venous thrombosis in one of the participating hospitals in- and out-patient clinics of the participating centers in Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are currently being treated in one of the participating centers, will be asked to participate in the study.
Detailed description
Background Outcome measures: Primary: Liver venous thrombosis recanalization Secondary: Thrombosis progression, Overall mortality, Major bleeding, Ascites Objective * To start a prospective observational cohort study of Liver Venous Thrombosis patients in Switzerland from their primary diagnosis and already diagnosed patients. * To examine long-term medical outcomes in patients with liver venous thrombosis in Switzerland by defining incidence, risk factors and treatment results * To prospectively collect data on medical history, serious comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and complications. * To store in a biobank blood and biological samples, obtained during routine practice Methods N/A
Interventions
None listed
Sponsors
Foundation for Liver Research
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Admitted in hospital or attend outpatient clinic * Objectively confirmed portal vein thrombosis and/or hepatic vein thrombosis * Budd-Chiari-Syndrome (BCS), Non-Cirrhotic Intrahepatic Portal Hypertension (NCIPH), Sinusoidal Obstructive Syndrome (SOS), Other Vascular Diseases (Hepatoportal Sclerosis (HC), Nodular Regenerative Hyperplasia (NRH), Obliterative Portal Venopathy (OPV) or Idiopathic Portal Hypertension (IPH)) * Subjects willing to provide informed consent
Exclusion criteria
* Thrombosis limited to mesenteric or splenic vein * Inability to sign consent form * Follow-up not possible * Cardiovascular, tumoral, pulmonary comorbidity with life expectancy estimated to be less than 6 months * Portal vein invasion by hepatocellular carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with liver venous thrombosis recanalization | End of study, expected to be on average after 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of patient with thrombosis recurrence and progression | End of study, expected to be on average after 5 years |
| Overall mortality | End of study, expected to be on average after 5 years |
| Number of patients with major bleeding | End of study, expected to be on average after 5 years |
| Number of patients with ascites | End of study, expected to be on average after 5 years |
Countries
Switzerland
Contacts
Primary ContactAndrea De Gottardi, Prof. Dr. med.
Outcome results
None listed