Swiss Liver Venous Thrombosis Study

Observational Study Clinical Trial

— SLVTS-SASL-35  

Official title:

A Multicenter Prospective Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01983059
• Other study ID #: SLVTS-SASL-35
• Status: Recruiting
• Start date: March 18, 2014
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Andrea De Gottardi, Prof. Dr. med.
• Phone: 031 632 38 13
• Email: andrea.degottardi[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Observational Study

Locations

Country	Name	City	State
Switzerland	Medizinische Klinik - Kantonsspital Baden	Baden
Switzerland	Klinik für Gastroenterologie und Hepatologie, Universtätsspital Basel	Basel	Kanton Basel
Switzerland	Department of Clinical Research, Hepatology Research Group	Bern	Kanton Bern
Switzerland	Service de Gastro-entérologie et Hépatologie, Hôpitaux Universtaires de Genève	Geneva
Switzerland	Service de Gastroentérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Centro di Epatologia - Clinica Luganese Moncucco	Lugano
Switzerland	Klinik für Gastroenterologie/Hepatologie, Kantonsspital St. Gallen	St. Gallen
Switzerland	Klinik für Gastroenterologie und Hepatologie Universitätsspital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Foundation for Liver Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with liver venous thrombosis recanalization		End of study, expected to be on average after 5 years
Secondary	Number of patient with thrombosis recurrence and progression		End of study, expected to be on average after 5 years
Secondary	Overall mortality		End of study, expected to be on average after 5 years
Secondary	Number of patients with major bleeding		End of study, expected to be on average after 5 years
Secondary	Number of patients with ascites		End of study, expected to be on average after 5 years