Clinical trial NCT01983059: Swiss Liver Venous Thrombosis Study
Official title: A Multicenter Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Observational Study
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Foundation for Liver Research
First posted: 2013-11-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Liver Venous Thrombosis patients in participating hospitals in Switzerland

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with liver venous thrombosis recanalization
timeFrame: End of study, expected to be on average after 5 years
Secondary outcomes:
measure: Number of patient with thrombosis recurrence and progression
timeFrame: End of study, expected to be on average after 5 years
measure: Overall mortality
timeFrame: End of study, expected to be on average after 5 years
measure: Number of patients with major bleeding
timeFrame: End of study, expected to be on average after 5 years
measure: Number of patients with ascites
timeFrame: End of study, expected to be on average after 5 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Klinik für Gastroenterologie und Hepatologie, Universtätsspital Basel
state: Kanton Basel
city: Bern
country: Switzerland
facility: Department of Clinical Research, Hepatology Research Group
state: Kanton Bern
city: Baden
country: Switzerland
facility: Medizinische Klinik - Kantonsspital Baden
city: Geneva
country: Switzerland
facility: Service de Gastro-entérologie et Hépatologie, Hôpitaux Universtaires de Genève
city: Lausanne
country: Switzerland
facility: Service de Gastroentérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois
city: Lugano
country: Switzerland
facility: Centro di Epatologia - Clinica Luganese Moncucco
city: St. Gallen
country: Switzerland
facility: Klinik für Gastroenterologie/Hepatologie, Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Klinik für Gastroenterologie und Hepatologie Universitätsspital Zürich
Study officials:
affiliation: Inselspital (University Hospital) Bern
name: Andrea De Gottardi, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: